QbD based development of HPLC method for simultaneous quantification of Telmisartan and Hydrochlorothiazide impurities in tablets dosage form
A simple reverse phase liquid chromatographic gradient method has been developed and validated for the simultaneous determination of specified & un-specified impurities of Telmisartan and Hydrochlorothiazide in combination oral solid dosage forms. The developed method is effective to separate a...
Saved in:
| Published in: | Practical laboratory medicine Vol. 21; p. e00169 |
|---|---|
| Main Authors: | , , |
| Format: | Journal Article |
| Language: | English |
| Published: |
Elsevier B.V
01.08.2020
Elsevier |
| Subjects: | |
| ISSN: | 2352-5517, 2352-5517 |
| Online Access: | Get full text |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| Abstract | A simple reverse phase liquid chromatographic gradient method has been developed and validated for the simultaneous determination of specified & un-specified impurities of Telmisartan and Hydrochlorothiazide in combination oral solid dosage forms. The developed method is effective to separate a total of sixteen (16) peaks and quantify eleven (11) specified impurities of Telmisartan and three (3) specified impurities of Hydrochlorothiazide with a minimum chromatographic resolution of 2.5. The separation was acquired with Inertsil ODS-3V, 150 × 4.6 mm, 3.5 μm column at a flow rate of 1.0 mL min-1 with the mobile phase-A consists of 0.02 M potassium dihydrogen phosphate (pH of 3.5) and mobile phase-B consists of a mixture of Milli-Q water and acetonitrile (100: 900 v/v) respectively. The detection of impurities was carried out at 230 nm and column temperature was maintained at 40 °C. Further optimized chromatographic conditions were applied to design of experiments to find out the critical quality attributes and established the design space. The binary combination of drug product was subjected to the different stress conditions such as acid, base, oxidation, heat and photolysis as per the recommendations of international conference on harmonization (Q2). The degradation Product found in stress patterns are well separated among main analyte compounds. The method was validated to be specific, robust and rugged in terms of change of chromatographic, instrumental and technical variables.
[Display omitted] |
|---|---|
| AbstractList | A simple reverse phase liquid chromatographic gradient method has been developed and validated for the simultaneous determination of specified & un-specified impurities of Telmisartan and Hydrochlorothiazide in combination oral solid dosage forms. The developed method is effective to separate a total of sixteen (16) peaks and quantify eleven (11) specified impurities of Telmisartan and three (3) specified impurities of Hydrochlorothiazide with a minimum chromatographic resolution of 2.5. The separation was acquired with Inertsil ODS-3V, 150 × 4.6 mm, 3.5 μm column at a flow rate of 1.0 mL min-1 with the mobile phase-A consists of 0.02 M potassium dihydrogen phosphate (pH of 3.5) and mobile phase-B consists of a mixture of Milli-Q water and acetonitrile (100: 900 v/v) respectively. The detection of impurities was carried out at 230 nm and column temperature was maintained at 40 °C. Further optimized chromatographic conditions were applied to design of experiments to find out the critical quality attributes and established the design space. The binary combination of drug product was subjected to the different stress conditions such as acid, base, oxidation, heat and photolysis as per the recommendations of international conference on harmonization (Q2). The degradation Product found in stress patterns are well separated among main analyte compounds. The method was validated to be specific, robust and rugged in terms of change of chromatographic, instrumental and technical variables.
Image 1 A simple reverse phase liquid chromatographic gradient method has been developed and validated for the simultaneous determination of specified & un-specified impurities of Telmisartan and Hydrochlorothiazide in combination oral solid dosage forms. The developed method is effective to separate a total of sixteen (16) peaks and quantify eleven (11) specified impurities of Telmisartan and three (3) specified impurities of Hydrochlorothiazide with a minimum chromatographic resolution of 2.5. The separation was acquired with Inertsil ODS-3V, 150 × 4.6 mm, 3.5 μm column at a flow rate of 1.0 mL min-1 with the mobile phase-A consists of 0.02 M potassium dihydrogen phosphate (pH of 3.5) and mobile phase-B consists of a mixture of Milli-Q water and acetonitrile (100: 900 v/v) respectively. The detection of impurities was carried out at 230 nm and column temperature was maintained at 40 °C. Further optimized chromatographic conditions were applied to design of experiments to find out the critical quality attributes and established the design space. The binary combination of drug product was subjected to the different stress conditions such as acid, base, oxidation, heat and photolysis as per the recommendations of international conference on harmonization (Q2). The degradation Product found in stress patterns are well separated among main analyte compounds. The method was validated to be specific, robust and rugged in terms of change of chromatographic, instrumental and technical variables. A simple reverse phase liquid chromatographic gradient method has been developed and validated for the simultaneous determination of specified & un-specified impurities of Telmisartan and Hydrochlorothiazide in combination oral solid dosage forms. The developed method is effective to separate a total of sixteen (16) peaks and quantify eleven (11) specified impurities of Telmisartan and three (3) specified impurities of Hydrochlorothiazide with a minimum chromatographic resolution of 2.5. The separation was acquired with Inertsil ODS-3V, 150 × 4.6 mm, 3.5 μm column at a flow rate of 1.0 mL min-1 with the mobile phase-A consists of 0.02 M potassium dihydrogen phosphate (pH of 3.5) and mobile phase-B consists of a mixture of Milli-Q water and acetonitrile (100: 900 v/v) respectively. The detection of impurities was carried out at 230 nm and column temperature was maintained at 40 °C. Further optimized chromatographic conditions were applied to design of experiments to find out the critical quality attributes and established the design space. The binary combination of drug product was subjected to the different stress conditions such as acid, base, oxidation, heat and photolysis as per the recommendations of international conference on harmonization (Q2). The degradation Product found in stress patterns are well separated among main analyte compounds. The method was validated to be specific, robust and rugged in terms of change of chromatographic, instrumental and technical variables.A simple reverse phase liquid chromatographic gradient method has been developed and validated for the simultaneous determination of specified & un-specified impurities of Telmisartan and Hydrochlorothiazide in combination oral solid dosage forms. The developed method is effective to separate a total of sixteen (16) peaks and quantify eleven (11) specified impurities of Telmisartan and three (3) specified impurities of Hydrochlorothiazide with a minimum chromatographic resolution of 2.5. The separation was acquired with Inertsil ODS-3V, 150 × 4.6 mm, 3.5 μm column at a flow rate of 1.0 mL min-1 with the mobile phase-A consists of 0.02 M potassium dihydrogen phosphate (pH of 3.5) and mobile phase-B consists of a mixture of Milli-Q water and acetonitrile (100: 900 v/v) respectively. The detection of impurities was carried out at 230 nm and column temperature was maintained at 40 °C. Further optimized chromatographic conditions were applied to design of experiments to find out the critical quality attributes and established the design space. The binary combination of drug product was subjected to the different stress conditions such as acid, base, oxidation, heat and photolysis as per the recommendations of international conference on harmonization (Q2). The degradation Product found in stress patterns are well separated among main analyte compounds. The method was validated to be specific, robust and rugged in terms of change of chromatographic, instrumental and technical variables. A simple reverse phase liquid chromatographic gradient method has been developed and validated for the simultaneous determination of specified & un-specified impurities of Telmisartan and Hydrochlorothiazide in combination oral solid dosage forms. The developed method is effective to separate a total of sixteen (16) peaks and quantify eleven (11) specified impurities of Telmisartan and three (3) specified impurities of Hydrochlorothiazide with a minimum chromatographic resolution of 2.5. The separation was acquired with Inertsil ODS-3V, 150 × 4.6 mm, 3.5 μm column at a flow rate of 1.0 mL min-1 with the mobile phase-A consists of 0.02 M potassium dihydrogen phosphate (pH of 3.5) and mobile phase-B consists of a mixture of Milli-Q water and acetonitrile (100: 900 v/v) respectively. The detection of impurities was carried out at 230 nm and column temperature was maintained at 40 °C. Further optimized chromatographic conditions were applied to design of experiments to find out the critical quality attributes and established the design space. The binary combination of drug product was subjected to the different stress conditions such as acid, base, oxidation, heat and photolysis as per the recommendations of international conference on harmonization (Q2). The degradation Product found in stress patterns are well separated among main analyte compounds. The method was validated to be specific, robust and rugged in terms of change of chromatographic, instrumental and technical variables. [Display omitted] |
| ArticleNumber | e00169 |
| Author | Palakurthi, Ashok K. Dongala, Thirupathi Katakam, Lakshmi Narasimha R. |
| Author_xml | – sequence: 1 givenname: Ashok K. surname: Palakurthi fullname: Palakurthi, Ashok K. email: ashokchem2000@gmail.com organization: Aurex Laboratories LLC, 10 Lake Dr, East Windsor, NJ, 08520, USA – sequence: 2 givenname: Thirupathi surname: Dongala fullname: Dongala, Thirupathi email: thirupathi2009@gmail.com organization: Aurex Laboratories LLC, 10 Lake Dr, East Windsor, NJ, 08520, USA – sequence: 3 givenname: Lakshmi Narasimha R. surname: Katakam fullname: Katakam, Lakshmi Narasimha R. organization: Analytical Development, Saptalis Pharmaceuticals LLC, Hauppauge, NY, USA, 11788 |
| BookMark | eNqFUsFu1DAUjFARLaVfwMVHLrs4TuzEB5DQFthKKwFSOVsv9suuV068tZ2Vyj_wz3ibClEOcLGt55l59rx5WZyNfsSieF3SZUlL8Xa_PDjohiWjjC6R5pJ8VlywirMF52Vz9sf5vLiKcU8zpm0aSdmL4rxioqyoaC-Kn9-6a9JBREMMHtH5w4BjIr4n66-bFRkw7bwhvQ8k2mFyCUb0UyR3E4zJ9lZDsn48wW_RDTZCyAgCoyHrexO83jkffNpZ-GENEjscpmCTxUjsSBJ0DlMkxkfY4qnH8Kp43oOLePW4XxbfP328Xa0Xmy-fb1YfNgvNKUuLtuW1oAgaDRO8zkvLG6wq3VeS1iU2FBAlK43ogHPDWS-brgTgrBONlKa6LG5mXeNhrw7BDhDulQerHgo-bFX-idUOVV2LhjMKIFuoBRdQa41ZRMhSUiGbrPV-1jpM3YBGZ_sCuCeiT29Gu1Nbf1RNxRiVdRZ48ygQ_N2EMalspEbnZq8Vq0vZ5KE3MkOrGaqDjzFg_7tNSdUpFyr_5pQLdcqFmnORWfIvlrbpYXD5Pdb9h_tu5mIex9FiUFFbHLPzNqBO2S_7T_4vySjYZQ |
| CitedBy_id | crossref_primary_10_1002_sscp_202300018 crossref_primary_10_2174_1573412919666230118105908 crossref_primary_10_1002_bmc_5152 crossref_primary_10_3390_separations8060086 crossref_primary_10_1002_bmc_5096 crossref_primary_10_1007_s00769_024_01608_8 crossref_primary_10_1002_bmc_5192 crossref_primary_10_1007_s11094_023_02826_z crossref_primary_10_3390_pharmaceutics14061187 crossref_primary_10_13005_bpj_2745 crossref_primary_10_1002_bmc_5019 crossref_primary_10_1002_sscp_202200086 crossref_primary_10_3390_molecules27134209 crossref_primary_10_1007_s10337_020_03945_5 crossref_primary_10_1080_10408347_2022_2032587 crossref_primary_10_1002_bmc_5247 crossref_primary_10_1186_s43094_023_00537_6 crossref_primary_10_1002_bmc_5121 crossref_primary_10_1002_bmc_5062 crossref_primary_10_1002_bmc_5086 crossref_primary_10_1002_bab_2765 crossref_primary_10_1080_10408347_2021_2008226 crossref_primary_10_1002_bmc_70031 crossref_primary_10_1080_10408347_2023_2253321 crossref_primary_10_1002_sscp_202200117 crossref_primary_10_1016_j_jics_2024_101521 crossref_primary_10_52711_0974_360X_2022_00072 crossref_primary_10_1080_10826076_2023_2204238 crossref_primary_10_1002_sscp_202000029 |
| Cites_doi | 10.13005/ojc/330349 10.1016/j.jpha.2017.06.001 10.1016/j.talanta.2010.10.011 10.1080/10826076.2013.765457 10.1124/jpet.119.256446 10.1016/j.jpba.2008.08.021 10.1002/bmc.4608 10.1080/22297928.2019.1696701 10.1002/bmc.4827 10.1186/s40543-019-0171-7 10.1016/S0731-7085(02)00643-X 10.1007/s10337-017-3339-6 10.1016/j.jpba.2011.04.015 10.3797/scipharm.1210-18 10.1016/j.farmac.2005.06.009 10.1016/j.jpba.2009.04.015 10.1016/j.aca.2005.03.004 |
| ContentType | Journal Article |
| Copyright | 2020 2020 Published by Elsevier B.V. 2020 Published by Elsevier B.V. 2020 |
| Copyright_xml | – notice: 2020 – notice: 2020 Published by Elsevier B.V. – notice: 2020 Published by Elsevier B.V. 2020 |
| DBID | 6I. AAFTH AAYXX CITATION 7X8 5PM DOA |
| DOI | 10.1016/j.plabm.2020.e00169 |
| DatabaseName | ScienceDirect Open Access Titles Elsevier:ScienceDirect:Open Access CrossRef MEDLINE - Academic PubMed Central (Full Participant titles) DOAJ Directory of Open Access Journals |
| DatabaseTitle | CrossRef MEDLINE - Academic |
| DatabaseTitleList | MEDLINE - Academic |
| Database_xml | – sequence: 1 dbid: DOA name: DOAJ Directory of Open Access Journals url: https://www.doaj.org/ sourceTypes: Open Website – sequence: 2 dbid: 7X8 name: MEDLINE - Academic url: https://search.proquest.com/medline sourceTypes: Aggregation Database |
| DeliveryMethod | fulltext_linktorsrc |
| Discipline | Medicine |
| EISSN | 2352-5517 |
| ExternalDocumentID | oai_doaj_org_article_4467520aa98a4656a4cce79969190697 PMC7322094 10_1016_j_plabm_2020_e00169 S2352551719301477 |
| GroupedDBID | 0R~ 0SF 4.4 457 53G 6I. AACTN AAEDW AAFTH AAFWJ AALRI AAXUO ABMAC ACGFS ADBBV ADEZE AEXQZ AFPKN AFTJW AGHFR AITUG ALMA_UNASSIGNED_HOLDINGS AMRAJ AOIJS BCNDV EBS EJD FDB GROUPED_DOAJ HYE KQ8 M~E NCXOZ O9- OK1 ROL RPM SSZ AAYWO AAYXX ACVFH ADCNI ADVLN AEUPX AFJKZ AFPUW AIGII AKBMS AKRWK AKYEP APXCP CITATION 7X8 5PM |
| ID | FETCH-LOGICAL-c502t-885460eaced2654d26857e33cf39041e70aee921d6ba55d52f97b1aa52b6799d3 |
| IEDL.DBID | DOA |
| ISICitedReferencesCount | 34 |
| ISICitedReferencesURI | http://www.webofscience.com/api/gateway?GWVersion=2&SrcApp=Summon&SrcAuth=ProQuest&DestLinkType=CitingArticles&DestApp=WOS_CPL&KeyUT=000559212400001&url=https%3A%2F%2Fcvtisr.summon.serialssolutions.com%2F%23%21%2Fsearch%3Fho%3Df%26include.ft.matches%3Dt%26l%3Dnull%26q%3D |
| ISSN | 2352-5517 |
| IngestDate | Fri Oct 03 12:36:32 EDT 2025 Tue Sep 30 16:48:45 EDT 2025 Thu Jul 10 23:42:35 EDT 2025 Thu Nov 13 04:34:41 EST 2025 Tue Nov 18 22:11:28 EST 2025 Tue Jul 25 21:04:04 EDT 2023 |
| IsDoiOpenAccess | true |
| IsOpenAccess | true |
| IsPeerReviewed | true |
| IsScholarly | true |
| Keywords | Solid dosage form Stability indicating Analytical quality by design Hydrochlorothiazide Design of experiments HPLC-UV Telmisartan |
| Language | English |
| License | This is an open access article under the CC BY-NC-ND license. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). |
| LinkModel | DirectLink |
| MergedId | FETCHMERGED-LOGICAL-c502t-885460eaced2654d26857e33cf39041e70aee921d6ba55d52f97b1aa52b6799d3 |
| Notes | ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 |
| OpenAccessLink | https://doaj.org/article/4467520aa98a4656a4cce79969190697 |
| PMID | 32613068 |
| PQID | 2419710179 |
| PQPubID | 23479 |
| ParticipantIDs | doaj_primary_oai_doaj_org_article_4467520aa98a4656a4cce79969190697 pubmedcentral_primary_oai_pubmedcentral_nih_gov_7322094 proquest_miscellaneous_2419710179 crossref_primary_10_1016_j_plabm_2020_e00169 crossref_citationtrail_10_1016_j_plabm_2020_e00169 elsevier_sciencedirect_doi_10_1016_j_plabm_2020_e00169 |
| PublicationCentury | 2000 |
| PublicationDate | 2020-08-01 |
| PublicationDateYYYYMMDD | 2020-08-01 |
| PublicationDate_xml | – month: 08 year: 2020 text: 2020-08-01 day: 01 |
| PublicationDecade | 2020 |
| PublicationTitle | Practical laboratory medicine |
| PublicationYear | 2020 |
| Publisher | Elsevier B.V Elsevier |
| Publisher_xml | – name: Elsevier B.V – name: Elsevier |
| References | Janga, Tatke, Dudhipala, Balguri (bib32) 2019; 370 Bhavani, Siva Rao, Raju (bib13) 2013; 3 Ashok, Thirupathi, Ravindra Kumar, Jayashree (bib19) 2017; 33 Krull, Swartz, Turpin (bib26) 2009; 27 Hillaert, Van den Bossche (bib10) 2003; 26 Anderson, Patrick (bib25) 2004 Jaivik, Jignesh, Pranav (bib6) 2017; 7 Rao, Reddy, Babu, Raju (bib22) 2010; 1 Yan, Li, Gu (bib5) 2008; 48 Monks, Rieger, Molnar (bib28) 2011; 56 Lories, Samah, Abbas (bib8) 2005; 60 Kumar, Raju, Thirupathi (bib30) 2013; 81 (bib14) 2005 Brunetto, Contreras, Martin (bib9) 2009; 50 Yan (bib4) 2008; 48 Mukhopadhyay, Kadam, Sawant (bib11) 2011; 3 Reid, Cheng, Fortin (bib24) 2013 Ismail Salama (bib3) 2011; 49 Balakrishna, Kumar, Jain (bib12) 2019; 3 Gupta, Jain, Lukram (bib7) 2011; 83 Rao, Rao (bib18) 2017; 80 Rama Mohana Reddy, Praveen Kumar, Krishna Reddy (bib23) 2012; 4 Dongala, Katari, Palakurthi (bib29) 2019; 33 Chen, Liang, Wang (bib2) 2005; 540 Rao, Krishnaiah, Babu, Reddy (bib15) 2014; 18 Rao, Krishnaiah, Reddy (bib17) 2015; 6 Dongala, Lakshmi Narasimha Rao (bib21) 2019; 9 Dongala, Palakurthi, Yytla, Katari (bib16) 2019; 10 Katakam, Dongala (bib20) 2020 bib1 Karthik, King, Sandeep (bib31) 2018; 19 Dongala, Palakurthi (bib27) 2019; 5 Jaivik (10.1016/j.plabm.2020.e00169_bib6) 2017; 7 Ismail Salama (10.1016/j.plabm.2020.e00169_bib3) 2011; 49 Lories (10.1016/j.plabm.2020.e00169_bib8) 2005; 60 Rao (10.1016/j.plabm.2020.e00169_bib22) 2010; 1 Kumar (10.1016/j.plabm.2020.e00169_bib30) 2013; 81 Rao (10.1016/j.plabm.2020.e00169_bib18) 2017; 80 Dongala (10.1016/j.plabm.2020.e00169_bib27) 2019; 5 Janga (10.1016/j.plabm.2020.e00169_bib32) 2019; 370 Ashok (10.1016/j.plabm.2020.e00169_bib19) 2017; 33 Dongala (10.1016/j.plabm.2020.e00169_bib29) 2019; 33 Hillaert (10.1016/j.plabm.2020.e00169_bib10) 2003; 26 Reid (10.1016/j.plabm.2020.e00169_bib24) 2013 Gupta (10.1016/j.plabm.2020.e00169_bib7) 2011; 83 Dongala (10.1016/j.plabm.2020.e00169_bib16) 2019; 10 Rama Mohana Reddy (10.1016/j.plabm.2020.e00169_bib23) 2012; 4 Karthik (10.1016/j.plabm.2020.e00169_bib31) 2018; 19 Brunetto (10.1016/j.plabm.2020.e00169_bib9) 2009; 50 (10.1016/j.plabm.2020.e00169_bib14) 2005 Dongala (10.1016/j.plabm.2020.e00169_bib21) 2019; 9 Krull (10.1016/j.plabm.2020.e00169_bib26) 2009; 27 Bhavani (10.1016/j.plabm.2020.e00169_bib13) 2013; 3 Yan (10.1016/j.plabm.2020.e00169_bib5) 2008; 48 Mukhopadhyay (10.1016/j.plabm.2020.e00169_bib11) 2011; 3 Rao (10.1016/j.plabm.2020.e00169_bib17) 2015; 6 Katakam (10.1016/j.plabm.2020.e00169_bib20) 2020 Monks (10.1016/j.plabm.2020.e00169_bib28) 2011; 56 Yan (10.1016/j.plabm.2020.e00169_bib4) 2008; 48 Chen (10.1016/j.plabm.2020.e00169_bib2) 2005; 540 Balakrishna (10.1016/j.plabm.2020.e00169_bib12) 2019; 3 Anderson (10.1016/j.plabm.2020.e00169_bib25) 2004 Rao (10.1016/j.plabm.2020.e00169_bib15) 2014; 18 |
| References_xml | – start-page: 1780 year: 2005 end-page: 1783 ident: bib14 article-title: ICH Harmonised Tripartite Guideline Validation of analytical procedures: text and methodology Q2 (R1) publication-title: Validation of Compendial Procedures – volume: 18 start-page: 593 year: 2014 end-page: 600 ident: bib15 article-title: Development and validation of a stability-indicating LC method for simultaneous determination of related compounds of guaifenesin, terbutaline sulfate and ambroxol HCl in cough syrup formulation publication-title: J. Saudi Chem. Soc. – volume: 6 start-page: 5 year: 2015 end-page: 14 ident: bib17 article-title: Stability-Indicating method for simultaneous determination of polar and non-polar related compounds of Zidovudine in drug substance and drug product tablet form publication-title: Int. J. Res. Pharm. Sci. – volume: 3 start-page: 145 year: 2019 end-page: 165 ident: bib12 article-title: Development and validation of stability indicating HPLC method for the determination of process and degradation related impurities in telmisartan drug substance publication-title: Chem. Method. – volume: 1 start-page: 473 year: 2010 end-page: 480 ident: bib22 article-title: Simultaneous estimation of fluticasone propionate, azelastine hydrochloride, phenylethyl alcohol and benzalkonium chloride by RP-HPLC method in nasal spray preparations publication-title: Int. J. Res. Pharm. Sci. – volume: 19 start-page: 48 year: 2018 end-page: 59 ident: bib31 article-title: Photostability issues in pharmaceutical dosage forms and photostabilization publication-title: AAPS – volume: 56 start-page: 874 year: 2011 end-page: 879 ident: bib28 article-title: Expanding the term ‘‘Design Space’’ in high performance liquid chromatography (I) publication-title: J. Pharmaceut. Biomed. Anal. – volume: 48 start-page: 1225 year: 2008 end-page: 1229 ident: bib4 article-title: Liquid chromatographic-tandem mass spectrometric method for the simultaneous quantitation of telmisartan and hydrochlorothiazide in human plasma publication-title: J. Pharmaceut. Biomed. Anal. – volume: 10 start-page: 12 year: 2019 ident: bib16 article-title: A novel UPLC-PDA isocratic method for the quantification fulvestrant in oil-based pre-filled syringe injection matrix formulations publication-title: J. Anal. Sci.Tech. – volume: 80 start-page: 1211 year: 2017 end-page: 1224 ident: bib18 article-title: Development and validation of a stability-indicating LC method for determination of bexarotene in softgel dosage formulation publication-title: Chromatographia – volume: 83 start-page: 709 year: 2011 end-page: 716 ident: bib7 article-title: Simultaneous determination of ramipril, ramiprilat and telmisartan in human plasma using liquid chromatography tandem mass spectrometry publication-title: Talanta – volume: 81 start-page: 139 year: 2013 end-page: 150 ident: bib30 article-title: Development and validation of a stability-indicating LC-method for the simultaneous estimation of levodropropizine, chloropheniramine, methylparaben, propylparaben, and levodropropizine impurities publication-title: Sci. Pharm. – year: 2013 ident: bib24 article-title: Reversed phase liquid chromatographic method development in analytical quality by design framework publication-title: J. Liq. Chromatogr. Relat. Technol. – volume: 7 start-page: 309 year: 2017 end-page: 316 ident: bib6 article-title: Application of an LC–MS/MS method for the analysis of amlodipine, valsartan and hydrochlorothiazide in polypill for a bioequivalence study publication-title: J. Pharm. Anal. – volume: 5 start-page: 594 year: 2019 end-page: 607 ident: bib27 article-title: HPLC-UV method development for the determination of EDTA in oxycodone HCl oral liquids with derivatization technique. Robustness by design of experiments approach publication-title: Anal.Chem. Lett. – volume: 3 start-page: 2 year: 2013 ident: bib13 article-title: Stability indicating UPLC method for the estimation of telmisartan related substances in tablets formulation publication-title: Int. J. Sci. Res. Publ. – volume: 540 start-page: 367 year: 2005 end-page: 373 ident: bib2 article-title: Development and validation of liquid chromatography–mass spectrometry method for the determination of telmisartan in human plasma publication-title: Anal. Chim. Acta – volume: 60 start-page: 859 year: 2005 end-page: 867 ident: bib8 article-title: Application of first-derivative, ratio derivative spectrophotometry, TLC-densitometry and spectrofluorimetry for the simultaneous determination of telmisartan and hydrochlorothiazide in pharmaceutical dosage forms and plasma publication-title: Il Farmaco – volume: 33 start-page: 1461 year: 2017 end-page: 1468 ident: bib19 article-title: Simultaneous determination of related organic impurities of ibuprofen and paracetamol in combination solid dosage form by Rp-hplc with Qbd approach publication-title: Orient. J. Chem. – volume: 4 start-page: 497 year: 2012 end-page: 504 ident: bib23 article-title: Stability-indicating hplc method for simultaneous estimation of low level impurities of telmisartan and hydrochlorothiazide in tablet dosage forms publication-title: Int. J. Pharm. Pharmaceut. Sci. – volume: 49 start-page: 19 year: 2011 end-page: 24 ident: bib3 article-title: Simultaneous HPLC–UV analysis of telmisartan and hydrochlorothiazide in human plasma publication-title: Bullet. Facul. Pharm. – year: 2020 ident: bib20 article-title: A novel RP-HPLC refractive index detector method development and validation for determination of trace-level alcohols (un-sulfated) in sodium lauryl sulfate raw material publication-title: Biomed. Chromatogr. – volume: 33 year: 2019 ident: bib29 article-title: Stability-indicating HPLC method for simultaneous quantification of 14 impurities in excedrin tablet formulations and identification of new impurity by LC–MS in accelerated stability studies publication-title: Biomed. Chromatogr. – year: 2004 ident: bib25 article-title: RSM Simplified: Optimizing Processes Using Response Surface Methods for Design of Experiments – volume: 48 start-page: 1225 year: 2008 end-page: 1229 ident: bib5 article-title: Liquid chromatographic–tandem mass spectrometric method for the simultaneous quantitation of telmisartan and hydrochlorothiazide in human plasma publication-title: J. Pharmaceut. Biomed. Anal. – volume: 50 start-page: 194 year: 2009 end-page: 199 ident: bib9 article-title: Determination of losartan, telmisartan, and valsartan by direct injection of human urine into a column-switching liquid chromatographic system with fluorescence detection publication-title: J. Pharmaceut. Biomed. Anal. – ident: bib1 – volume: 26 start-page: 329 year: 2003 end-page: 339 ident: bib10 article-title: Simultaneous determination of hydrochlorothiazide and several angiotensin-II-receptor antagonists by capillary electrophoresis publication-title: J. Pharmaceut. Biomed. Anal. – volume: 9 start-page: 697 year: 2019 end-page: 710 ident: bib21 article-title: RP-HPLC stability indicating method development and validation of pseudoephedrine sulfate and related organic impurities in tablet dosage forms, robustness by QbD approach publication-title: Anal. Chem. Lett. – volume: 27 start-page: 48 year: 2009 end-page: 61 ident: bib26 article-title: A quality-by-design methodology for rapid LC method development publication-title: LC-GC N. Am. – volume: 3 start-page: 3 year: 2011 ident: bib11 article-title: Simultaneous determination of related substances of telmisartan and hydrochlorothiazide in tablet dosage form by using reversed phase high performance liquid chromatographic method publication-title: J. Pharm. Bioanal. Sci. – volume: 370 start-page: 814 year: 2019 end-page: 822 ident: bib32 article-title: Gellan gum based sol-to-gel transforming system of natamycin transfersomes improves topical ocular delivery publication-title: J.Pharm. Exp. Ther. – start-page: 1780 year: 2005 ident: 10.1016/j.plabm.2020.e00169_bib14 article-title: ICH Harmonised Tripartite Guideline Validation of analytical procedures: text and methodology Q2 (R1) – volume: 33 start-page: 1461 year: 2017 ident: 10.1016/j.plabm.2020.e00169_bib19 article-title: Simultaneous determination of related organic impurities of ibuprofen and paracetamol in combination solid dosage form by Rp-hplc with Qbd approach publication-title: Orient. J. Chem. doi: 10.13005/ojc/330349 – volume: 7 start-page: 309 year: 2017 ident: 10.1016/j.plabm.2020.e00169_bib6 article-title: Application of an LC–MS/MS method for the analysis of amlodipine, valsartan and hydrochlorothiazide in polypill for a bioequivalence study publication-title: J. Pharm. Anal. doi: 10.1016/j.jpha.2017.06.001 – volume: 3 start-page: 2 year: 2013 ident: 10.1016/j.plabm.2020.e00169_bib13 article-title: Stability indicating UPLC method for the estimation of telmisartan related substances in tablets formulation publication-title: Int. J. Sci. Res. Publ. – volume: 83 start-page: 709 year: 2011 ident: 10.1016/j.plabm.2020.e00169_bib7 article-title: Simultaneous determination of ramipril, ramiprilat and telmisartan in human plasma using liquid chromatography tandem mass spectrometry publication-title: Talanta doi: 10.1016/j.talanta.2010.10.011 – year: 2013 ident: 10.1016/j.plabm.2020.e00169_bib24 article-title: Reversed phase liquid chromatographic method development in analytical quality by design framework publication-title: J. Liq. Chromatogr. Relat. Technol. doi: 10.1080/10826076.2013.765457 – volume: 370 start-page: 814 year: 2019 ident: 10.1016/j.plabm.2020.e00169_bib32 article-title: Gellan gum based sol-to-gel transforming system of natamycin transfersomes improves topical ocular delivery publication-title: J.Pharm. Exp. Ther. doi: 10.1124/jpet.119.256446 – volume: 1 start-page: 473 issue: 4 year: 2010 ident: 10.1016/j.plabm.2020.e00169_bib22 article-title: Simultaneous estimation of fluticasone propionate, azelastine hydrochloride, phenylethyl alcohol and benzalkonium chloride by RP-HPLC method in nasal spray preparations publication-title: Int. J. Res. Pharm. Sci. – volume: 48 start-page: 1225 year: 2008 ident: 10.1016/j.plabm.2020.e00169_bib5 article-title: Liquid chromatographic–tandem mass spectrometric method for the simultaneous quantitation of telmisartan and hydrochlorothiazide in human plasma publication-title: J. Pharmaceut. Biomed. Anal. doi: 10.1016/j.jpba.2008.08.021 – volume: 33 issue: 10 year: 2019 ident: 10.1016/j.plabm.2020.e00169_bib29 article-title: Stability-indicating HPLC method for simultaneous quantification of 14 impurities in excedrin tablet formulations and identification of new impurity by LC–MS in accelerated stability studies publication-title: Biomed. Chromatogr. doi: 10.1002/bmc.4608 – volume: 6 start-page: 5 issue: 1 year: 2015 ident: 10.1016/j.plabm.2020.e00169_bib17 article-title: Stability-Indicating method for simultaneous determination of polar and non-polar related compounds of Zidovudine in drug substance and drug product tablet form publication-title: Int. J. Res. Pharm. Sci. – volume: 4 start-page: 497 year: 2012 ident: 10.1016/j.plabm.2020.e00169_bib23 article-title: Stability-indicating hplc method for simultaneous estimation of low level impurities of telmisartan and hydrochlorothiazide in tablet dosage forms publication-title: Int. J. Pharm. Pharmaceut. Sci. – volume: 9 start-page: 697 issue: 5 year: 2019 ident: 10.1016/j.plabm.2020.e00169_bib21 article-title: RP-HPLC stability indicating method development and validation of pseudoephedrine sulfate and related organic impurities in tablet dosage forms, robustness by QbD approach publication-title: Anal. Chem. Lett. doi: 10.1080/22297928.2019.1696701 – year: 2020 ident: 10.1016/j.plabm.2020.e00169_bib20 article-title: A novel RP-HPLC refractive index detector method development and validation for determination of trace-level alcohols (un-sulfated) in sodium lauryl sulfate raw material publication-title: Biomed. Chromatogr. doi: 10.1002/bmc.4827 – volume: 19 start-page: 48 year: 2018 ident: 10.1016/j.plabm.2020.e00169_bib31 article-title: Photostability issues in pharmaceutical dosage forms and photostabilization publication-title: AAPS – year: 2004 ident: 10.1016/j.plabm.2020.e00169_bib25 – volume: 49 start-page: 19 year: 2011 ident: 10.1016/j.plabm.2020.e00169_bib3 article-title: Simultaneous HPLC–UV analysis of telmisartan and hydrochlorothiazide in human plasma publication-title: Bullet. Facul. Pharm. – volume: 10 start-page: 12 year: 2019 ident: 10.1016/j.plabm.2020.e00169_bib16 article-title: A novel UPLC-PDA isocratic method for the quantification fulvestrant in oil-based pre-filled syringe injection matrix formulations publication-title: J. Anal. Sci.Tech. doi: 10.1186/s40543-019-0171-7 – volume: 26 start-page: 329 year: 2003 ident: 10.1016/j.plabm.2020.e00169_bib10 article-title: Simultaneous determination of hydrochlorothiazide and several angiotensin-II-receptor antagonists by capillary electrophoresis publication-title: J. Pharmaceut. Biomed. Anal. doi: 10.1016/S0731-7085(02)00643-X – volume: 3 start-page: 145 year: 2019 ident: 10.1016/j.plabm.2020.e00169_bib12 article-title: Development and validation of stability indicating HPLC method for the determination of process and degradation related impurities in telmisartan drug substance publication-title: Chem. Method. – volume: 80 start-page: 1211 issue: 8 year: 2017 ident: 10.1016/j.plabm.2020.e00169_bib18 article-title: Development and validation of a stability-indicating LC method for determination of bexarotene in softgel dosage formulation publication-title: Chromatographia doi: 10.1007/s10337-017-3339-6 – volume: 56 start-page: 874 issue: 2011 year: 2011 ident: 10.1016/j.plabm.2020.e00169_bib28 article-title: Expanding the term ‘‘Design Space’’ in high performance liquid chromatography (I) publication-title: J. Pharmaceut. Biomed. Anal. doi: 10.1016/j.jpba.2011.04.015 – volume: 48 start-page: 1225 year: 2008 ident: 10.1016/j.plabm.2020.e00169_bib4 article-title: Liquid chromatographic-tandem mass spectrometric method for the simultaneous quantitation of telmisartan and hydrochlorothiazide in human plasma publication-title: J. Pharmaceut. Biomed. Anal. doi: 10.1016/j.jpba.2008.08.021 – volume: 81 start-page: 139 issue: 1 year: 2013 ident: 10.1016/j.plabm.2020.e00169_bib30 article-title: Development and validation of a stability-indicating LC-method for the simultaneous estimation of levodropropizine, chloropheniramine, methylparaben, propylparaben, and levodropropizine impurities publication-title: Sci. Pharm. doi: 10.3797/scipharm.1210-18 – volume: 5 start-page: 594 year: 2019 ident: 10.1016/j.plabm.2020.e00169_bib27 article-title: HPLC-UV method development for the determination of EDTA in oxycodone HCl oral liquids with derivatization technique. Robustness by design of experiments approach publication-title: Anal.Chem. Lett. – volume: 60 start-page: 859 year: 2005 ident: 10.1016/j.plabm.2020.e00169_bib8 article-title: Application of first-derivative, ratio derivative spectrophotometry, TLC-densitometry and spectrofluorimetry for the simultaneous determination of telmisartan and hydrochlorothiazide in pharmaceutical dosage forms and plasma publication-title: Il Farmaco doi: 10.1016/j.farmac.2005.06.009 – volume: 50 start-page: 194 year: 2009 ident: 10.1016/j.plabm.2020.e00169_bib9 article-title: Determination of losartan, telmisartan, and valsartan by direct injection of human urine into a column-switching liquid chromatographic system with fluorescence detection publication-title: J. Pharmaceut. Biomed. Anal. doi: 10.1016/j.jpba.2009.04.015 – volume: 3 start-page: 3 year: 2011 ident: 10.1016/j.plabm.2020.e00169_bib11 article-title: Simultaneous determination of related substances of telmisartan and hydrochlorothiazide in tablet dosage form by using reversed phase high performance liquid chromatographic method publication-title: J. Pharm. Bioanal. Sci. – volume: 27 start-page: 48 year: 2009 ident: 10.1016/j.plabm.2020.e00169_bib26 article-title: A quality-by-design methodology for rapid LC method development publication-title: LC-GC N. Am. – volume: 18 start-page: 593 year: 2014 ident: 10.1016/j.plabm.2020.e00169_bib15 article-title: Development and validation of a stability-indicating LC method for simultaneous determination of related compounds of guaifenesin, terbutaline sulfate and ambroxol HCl in cough syrup formulation publication-title: J. Saudi Chem. Soc. – volume: 540 start-page: 367 year: 2005 ident: 10.1016/j.plabm.2020.e00169_bib2 article-title: Development and validation of liquid chromatography–mass spectrometry method for the determination of telmisartan in human plasma publication-title: Anal. Chim. Acta doi: 10.1016/j.aca.2005.03.004 |
| SSID | ssj0001877902 |
| Score | 2.3398416 |
| Snippet | A simple reverse phase liquid chromatographic gradient method has been developed and validated for the simultaneous determination of specified & un-specified... |
| SourceID | doaj pubmedcentral proquest crossref elsevier |
| SourceType | Open Website Open Access Repository Aggregation Database Enrichment Source Index Database Publisher |
| StartPage | e00169 |
| SubjectTerms | Analytical quality by design Design of experiments HPLC-UV Hydrochlorothiazide Solid dosage form Stability indicating Telmisartan |
| Title | QbD based development of HPLC method for simultaneous quantification of Telmisartan and Hydrochlorothiazide impurities in tablets dosage form |
| URI | https://dx.doi.org/10.1016/j.plabm.2020.e00169 https://www.proquest.com/docview/2419710179 https://pubmed.ncbi.nlm.nih.gov/PMC7322094 https://doaj.org/article/4467520aa98a4656a4cce79969190697 |
| Volume | 21 |
| WOSCitedRecordID | wos000559212400001&url=https%3A%2F%2Fcvtisr.summon.serialssolutions.com%2F%23%21%2Fsearch%3Fho%3Df%26include.ft.matches%3Dt%26l%3Dnull%26q%3D |
| hasFullText | 1 |
| inHoldings | 1 |
| isFullTextHit | |
| isPrint | |
| journalDatabaseRights | – providerCode: PRVAON databaseName: DOAJ Directory of Open Access Journals customDbUrl: eissn: 2352-5517 dateEnd: 99991231 omitProxy: false ssIdentifier: ssj0001877902 issn: 2352-5517 databaseCode: DOA dateStart: 20150101 isFulltext: true titleUrlDefault: https://www.doaj.org/ providerName: Directory of Open Access Journals – providerCode: PRVHPJ databaseName: ROAD: Directory of Open Access Scholarly Resources customDbUrl: eissn: 2352-5517 dateEnd: 99991231 omitProxy: false ssIdentifier: ssj0001877902 issn: 2352-5517 databaseCode: M~E dateStart: 20150101 isFulltext: true titleUrlDefault: https://road.issn.org providerName: ISSN International Centre |
| link | http://cvtisr.summon.serialssolutions.com/2.0.0/link/0/eLvHCXMwrV1Lb9QwELagQohLxVMsj8pIHAkkTvw6Qmm1h7YqUpH2ZtmxI4La7NLNVoID_4D_zIydlM2lvXDJIXESx9_E800y_oaQt00QzgMtyEStm6yqQpEpmBMzaUvXgP-t69rFYhPy5EQtFvp0q9QX5oQleeA0cB8gXJGc5dZqZVHby8LpQQJL1-DKhI7ryIH1bAVT8euKQh09FivLcYi2eCFHyaGY3LWCIcZ16Cx_H5D16Ilbiur9E--0xT6nuZNbzujwIdkdWCT9mHr_iNwJ3WNy_3j4T_6E_PniPlN0UJ76f1lBdNnQ-enRPk1loynwVbpuMaXQdmG5WdMfG5tyhyJc2PwsnIMhwCjZjtrO0_lPjzW2IMgHhFv7q_WBthcrLIEHITdtO9rjWqx-Tf0SU9bwHhdPydfDg7P9eTYUXshqnrM-U4pXIocpOXgmeAUbxWUoy7opdV4VQeY2BM0KL5zl3HPWaOkKazlzAqDx5TOy0y278JzQ4DgEOL6sHLcVNtKuKRwEOXnwXisxI2wcd1MPquRYHOPcjOln300EyyBYJoE1I--uT1olUY6bm39CQK-boqJ23AF2ZgY7M7fZ2YyI0RzMQE4S6YBLtTff_c1oPAYQw_8xCVQD5EnLOCXOiJxY1aSr0yNd-y2KgEuYiSE0f_E_nu0leYAdTnmNr8hOf7kJr8m9-qpv15d75K5cqL34fsH2-PfBX0a5K8s |
| linkProvider | Directory of Open Access Journals |
| openUrl | ctx_ver=Z39.88-2004&ctx_enc=info%3Aofi%2Fenc%3AUTF-8&rfr_id=info%3Asid%2Fsummon.serialssolutions.com&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=QbD+based+development+of+HPLC+method+for+simultaneous+quantification+of+Telmisartan+and+Hydrochlorothiazide+impurities+in+tablets+dosage+form&rft.jtitle=Practical+laboratory+medicine&rft.au=Ashok+K.+Palakurthi&rft.au=Thirupathi+Dongala&rft.au=Lakshmi+Narasimha+R.+Katakam&rft.date=2020-08-01&rft.pub=Elsevier&rft.issn=2352-5517&rft.eissn=2352-5517&rft.volume=21&rft.spage=e00169&rft_id=info:doi/10.1016%2Fj.plabm.2020.e00169&rft.externalDBID=DOA&rft.externalDocID=oai_doaj_org_article_4467520aa98a4656a4cce79969190697 |
| thumbnail_l | http://covers-cdn.summon.serialssolutions.com/index.aspx?isbn=/lc.gif&issn=2352-5517&client=summon |
| thumbnail_m | http://covers-cdn.summon.serialssolutions.com/index.aspx?isbn=/mc.gif&issn=2352-5517&client=summon |
| thumbnail_s | http://covers-cdn.summon.serialssolutions.com/index.aspx?isbn=/sc.gif&issn=2352-5517&client=summon |