Development and validation of simple spectrophotometric and chemometric methods for simultaneous determination of empagliflozin and metformin: Applied to recently approved pharmaceutical formulation
New univariate spectrophotometric method and multivariate chemometric approach were developed and compared for simultaneous determination of empagliflozin and metformin manipulating their zero order absorption spectra with application on their pharmaceutical preparation. Sample enrichment technique...
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| Veröffentlicht in: | Spectrochimica acta. Part A, Molecular and biomolecular spectroscopy Jg. 168; S. 118 - 122 |
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| Format: | Journal Article |
| Sprache: | Englisch |
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England
Elsevier B.V
05.11.2016
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| ISSN: | 1386-1425, 1873-3557, 1873-3557 |
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| Abstract | New univariate spectrophotometric method and multivariate chemometric approach were developed and compared for simultaneous determination of empagliflozin and metformin manipulating their zero order absorption spectra with application on their pharmaceutical preparation. Sample enrichment technique was used to increase concentration of empagliflozin after extraction from tablets to allow its simultaneous determination with metformin without prior separation. Validation parameters according to ICH guidelines were satisfactory over the concentration range of 2–12μgmL−1 for both drugs using simultaneous equation with LOD values equal to 0.20μgmL−1 and 0.19μgmL−1, LOQ values equal to 0.59μgmL−1 and 0.58μgmL−1 for empagliflozin and metformin, respectively. While the optimum results for the chemometric approach using partial least squares method (PLS-2) were obtained using concentration range of 2–10μgmL−1. The optimized validated methods are suitable for quality control laboratories enable fast and economic determination of the recently approved pharmaceutical combination Synjardy® tablets.
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•Simultaneous determination of empagliflozin and metformin•First spectrophotometric method for determination of empagliflozin and metformin•First chemometric method for determination of empagliflozin•Applicable on recently approved pharmaceutical dosage form•The proposed method is suitable for QC laboratories |
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| AbstractList | New univariate spectrophotometric method and multivariate chemometric approach were developed and compared for simultaneous determination of empagliflozin and metformin manipulating their zero order absorption spectra with application on their pharmaceutical preparation. Sample enrichment technique was used to increase concentration of empagliflozin after extraction from tablets to allow its simultaneous determination with metformin without prior separation. Validation parameters according to ICH guidelines were satisfactory over the concentration range of 2–12μgmL−1 for both drugs using simultaneous equation with LOD values equal to 0.20μgmL−1 and 0.19μgmL−1, LOQ values equal to 0.59μgmL−1 and 0.58μgmL−1 for empagliflozin and metformin, respectively. While the optimum results for the chemometric approach using partial least squares method (PLS-2) were obtained using concentration range of 2–10μgmL−1. The optimized validated methods are suitable for quality control laboratories enable fast and economic determination of the recently approved pharmaceutical combination Synjardy® tablets.
[Display omitted]
•Simultaneous determination of empagliflozin and metformin•First spectrophotometric method for determination of empagliflozin and metformin•First chemometric method for determination of empagliflozin•Applicable on recently approved pharmaceutical dosage form•The proposed method is suitable for QC laboratories New univariate spectrophotometric method and multivariate chemometric approach were developed and compared for simultaneous determination of empagliflozin and metformin manipulating their zero order absorption spectra with application on their pharmaceutical preparation. Sample enrichment technique was used to increase concentration of empagliflozin after extraction from tablets to allow its simultaneous determination with metformin without prior separation. Validation parameters according to ICH guidelines were satisfactory over the concentration range of 2-12μgmL(-1) for both drugs using simultaneous equation with LOD values equal to 0.20μgmL(-1) and 0.19μgmL(-1), LOQ values equal to 0.59μgmL(-1) and 0.58μgmL(-1) for empagliflozin and metformin, respectively. While the optimum results for the chemometric approach using partial least squares method (PLS-2) were obtained using concentration range of 2-10μgmL(-1). The optimized validated methods are suitable for quality control laboratories enable fast and economic determination of the recently approved pharmaceutical combination Synjardy® tablets.New univariate spectrophotometric method and multivariate chemometric approach were developed and compared for simultaneous determination of empagliflozin and metformin manipulating their zero order absorption spectra with application on their pharmaceutical preparation. Sample enrichment technique was used to increase concentration of empagliflozin after extraction from tablets to allow its simultaneous determination with metformin without prior separation. Validation parameters according to ICH guidelines were satisfactory over the concentration range of 2-12μgmL(-1) for both drugs using simultaneous equation with LOD values equal to 0.20μgmL(-1) and 0.19μgmL(-1), LOQ values equal to 0.59μgmL(-1) and 0.58μgmL(-1) for empagliflozin and metformin, respectively. While the optimum results for the chemometric approach using partial least squares method (PLS-2) were obtained using concentration range of 2-10μgmL(-1). The optimized validated methods are suitable for quality control laboratories enable fast and economic determination of the recently approved pharmaceutical combination Synjardy® tablets. New univariate spectrophotometric method and multivariate chemometric approach were developed and compared for simultaneous determination of empagliflozin and metformin manipulating their zero order absorption spectra with application on their pharmaceutical preparation. Sample enrichment technique was used to increase concentration of empagliflozin after extraction from tablets to allow its simultaneous determination with metformin without prior separation. Validation parameters according to ICH guidelines were satisfactory over the concentration range of 2-12μgmL(-1) for both drugs using simultaneous equation with LOD values equal to 0.20μgmL(-1) and 0.19μgmL(-1), LOQ values equal to 0.59μgmL(-1) and 0.58μgmL(-1) for empagliflozin and metformin, respectively. While the optimum results for the chemometric approach using partial least squares method (PLS-2) were obtained using concentration range of 2-10μgmL(-1). The optimized validated methods are suitable for quality control laboratories enable fast and economic determination of the recently approved pharmaceutical combination Synjardy® tablets. |
| Author | Ayoub, Bassam M. |
| Author_xml | – sequence: 1 givenname: Bassam M. surname: Ayoub fullname: Ayoub, Bassam M. email: bassam.ayoub@bue.edu.eg, drbassamchemistry@hotmail.com organization: Pharmaceutical Chemistry Department, Faculty of Pharmacy, British University in Egypt (BUE), El-Sherouk City, Cairo 11837, Egypt |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/27288963$$D View this record in MEDLINE/PubMed |
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| Cites_doi | 10.1039/a703654j 10.1210/jc.2009-0473 10.1039/C5RA17231D |
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| Keywords | Pharmaceutical preparation Empagliflozin Metformin Chemometry Partial least squares Simultaneous equation |
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| SubjectTerms | Benzhydryl Compounds - analysis Chemometry Empagliflozin Glucosides - analysis Hypoglycemic Agents - analysis Least-Squares Analysis Limit of Detection Metformin Metformin - analysis Partial least squares Pharmaceutical preparation Simultaneous equation Spectrophotometry - methods Tablets |
| Title | Development and validation of simple spectrophotometric and chemometric methods for simultaneous determination of empagliflozin and metformin: Applied to recently approved pharmaceutical formulation |
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