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Development and validation of R-HPLC method for simultaneous determination of fexofenadine HCl and paracetamol for their quantification from multiparticulate drug delivery system

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Názov: Development and validation of R-HPLC method for simultaneous determination of fexofenadine HCl and paracetamol for their quantification from multiparticulate drug delivery system
Autori: Muhammad Sajid Nawaz, Muhammad Hasnat, Muhammad Zaman, Majid Alhomrani, Abdulhakeem S. Alamri, Waqar Siddique, Muhammad Amer, null Qurat-ul-ain shoaib, Kanwal Shahzadi
Zdroj: Acta Chromatographica. 37:337-343
Informácie o vydavateľovi: Akademiai Kiado Zrt., 2025.
Rok vydania: 2025
Predmety: 01 natural sciences, 0104 chemical sciences, 0105 earth and related environmental sciences
Popis: In the field of pharmaceutical analysis, high-performance liquid chromatography (HPLC) is considered to be the key technique, which is one of the most efficient, quick, and easy methods for the simultaneous determination of two are more drugs. The purpose of the current study is to develop and validate the reversed-phase high-performance liquid chromatographic (RP-HPLC) method for the simultaneous determination of Paracetamol and Fexofenadine HCl. This approach was validated by the standards and The International Conference on Harmonization (ICH), and United States Pharmacopeia (USP) were followed in the development and validation of the method. The chromatographic conditions including a mobile phase comprised of a 35:65 buffer mix and acetonitrile with a 1.0 mL min−1 flow rate were used. A thorough investigation was performed, including linearity and range, specificity, robustness, accuracy, precision, solution stability, and system suitability. The outcomes of the studies have shown that, both Active Pharmaceutical ingredients i.e., Paracetamol and Fexofenadine HCl were separated in about 7.5 min. The variation coefficient for Paracetamol and fexofenadine HCl varied between 0.9992 R2 and 0.9983 R2, respectively. The devised method was proved accurate, as API recoveries in both cases of Paracetamol and Fexofenadine ranged from (99.79%, 100.72%, and 98.64%) to (99.96%, 100.64%, and 99.00%). The method's accuracy was further demonstrated by the solution stability which was 99.84% for Paracetamol, and 100.53% for Fexofenadine HCl. The suggested method for simultaneously measuring Paracetamol and Fexofenadine HCl was established, validated, and there was no evidence of any excipient interaction was observed.
Druh dokumentu: Article
ISSN: 2083-5736
1233-2356
DOI: 10.1556/1326.2024.01262
Rights: CC BY NC
Prístupové číslo: edsair.doi...........fa4a02e255bafd228ad53fe3ae3e4f7a
Databáza: OpenAIRE
Popis
Abstrakt:In the field of pharmaceutical analysis, high-performance liquid chromatography (HPLC) is considered to be the key technique, which is one of the most efficient, quick, and easy methods for the simultaneous determination of two are more drugs. The purpose of the current study is to develop and validate the reversed-phase high-performance liquid chromatographic (RP-HPLC) method for the simultaneous determination of Paracetamol and Fexofenadine HCl. This approach was validated by the standards and The International Conference on Harmonization (ICH), and United States Pharmacopeia (USP) were followed in the development and validation of the method. The chromatographic conditions including a mobile phase comprised of a 35:65 buffer mix and acetonitrile with a 1.0 mL min−1 flow rate were used. A thorough investigation was performed, including linearity and range, specificity, robustness, accuracy, precision, solution stability, and system suitability. The outcomes of the studies have shown that, both Active Pharmaceutical ingredients i.e., Paracetamol and Fexofenadine HCl were separated in about 7.5 min. The variation coefficient for Paracetamol and fexofenadine HCl varied between 0.9992 R2 and 0.9983 R2, respectively. The devised method was proved accurate, as API recoveries in both cases of Paracetamol and Fexofenadine ranged from (99.79%, 100.72%, and 98.64%) to (99.96%, 100.64%, and 99.00%). The method's accuracy was further demonstrated by the solution stability which was 99.84% for Paracetamol, and 100.53% for Fexofenadine HCl. The suggested method for simultaneously measuring Paracetamol and Fexofenadine HCl was established, validated, and there was no evidence of any excipient interaction was observed.
ISSN:20835736
12332356
DOI:10.1556/1326.2024.01262