Development and validation of an analytical method for the determination of related substances in bisoprolol fumarate in dosage forms by HPLC-UV-DAD
The aim of this work was the development of an efficient analytical method for the determination of bisoprolol and related substances in the finished drug product using HPLC/DAD. Different bonded phases (alkyl and phenyl) with variable pore sizes and column dimensions, temperatures, and mobile phas...
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| Format: | Article |
| Language: | English |
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Society of Chemists and Technologists of Macedonia
2021-12-01
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| Series: | Macedonian Journal of Chemistry and Chemical Engineering |
| Subjects: | |
| Online Access: | https://mjcce.org.mk/index.php/MJCCE/article/view/2430 |
| _version_ | 1818328004763320320 |
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| author | Elena Lazarevska Todevska Marjan Piponski Marina Stefova |
| author_facet | Elena Lazarevska Todevska Marjan Piponski Marina Stefova |
| author_sort | Elena Lazarevska Todevska |
| collection | DOAJ |
| description |
The aim of this work was the development of an efficient analytical method for the determination of bisoprolol and related substances in the finished drug product using HPLC/DAD. Different bonded phases (alkyl and phenyl) with variable pore sizes and column dimensions, temperatures, and mobile phases with variable pH and additives were tested. Experiments that included using Hypersil 3 BDS C18 100 × 4 mm, 3 mm; Zorbax SB C18 150 × 4.6 mm, 3.5 mm; Acquity UPLC BEH C18 50 × 2.1 mm, 1.7 mm; and Xterra MS C18 100 × 4.6 mm, 3.5 mm gave the best results when considering the separation and resolution of the tested analytes within a reasonable run time. The method using Xterra MS C18 100 × 4.6 mm, 3.5 mm was validated as the most suitable when taking into account the mobile phase preparation and versatility, analysis time, and equipment maintenance.
Validation parameters (linearity, accuracy, precision, selectivity) confirmed the method as suitable for its intended use.
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| first_indexed | 2024-12-13T12:25:16Z |
| format | Article |
| id | doaj.art-99dcccb707ac440d82f78e046af225cd |
| institution | Directory Open Access Journal |
| issn | 1857-5552 1857-5625 |
| language | English |
| last_indexed | 2024-12-13T12:25:16Z |
| publishDate | 2021-12-01 |
| publisher | Society of Chemists and Technologists of Macedonia |
| record_format | Article |
| series | Macedonian Journal of Chemistry and Chemical Engineering |
| spelling | doaj.art-99dcccb707ac440d82f78e046af225cd2022-12-21T23:46:22ZengSociety of Chemists and Technologists of MacedoniaMacedonian Journal of Chemistry and Chemical Engineering1857-55521857-56252021-12-0140210.20450/mjcce.2021.24301968Development and validation of an analytical method for the determination of related substances in bisoprolol fumarate in dosage forms by HPLC-UV-DADElena Lazarevska Todevska0Marjan Piponski1Marina Stefova2Replek Farm Ltd, Quality Control Department, Skopje and Institute of Chemistry, Faculty of Natural Sciences and Mathematics, Ss. Cyril and Methodius University, SkopjeReplek Farm Ltd, Quality Control Department, SkopjeInstitute of Chemistry, Faculty of Natural Sciences and Mathematics, Ss. Cyril and Methodius University, Skopje The aim of this work was the development of an efficient analytical method for the determination of bisoprolol and related substances in the finished drug product using HPLC/DAD. Different bonded phases (alkyl and phenyl) with variable pore sizes and column dimensions, temperatures, and mobile phases with variable pH and additives were tested. Experiments that included using Hypersil 3 BDS C18 100 × 4 mm, 3 mm; Zorbax SB C18 150 × 4.6 mm, 3.5 mm; Acquity UPLC BEH C18 50 × 2.1 mm, 1.7 mm; and Xterra MS C18 100 × 4.6 mm, 3.5 mm gave the best results when considering the separation and resolution of the tested analytes within a reasonable run time. The method using Xterra MS C18 100 × 4.6 mm, 3.5 mm was validated as the most suitable when taking into account the mobile phase preparation and versatility, analysis time, and equipment maintenance. Validation parameters (linearity, accuracy, precision, selectivity) confirmed the method as suitable for its intended use. https://mjcce.org.mk/index.php/MJCCE/article/view/2430bisoprololrelated substancesforced degradation studies |
| spellingShingle | Elena Lazarevska Todevska Marjan Piponski Marina Stefova Development and validation of an analytical method for the determination of related substances in bisoprolol fumarate in dosage forms by HPLC-UV-DAD Macedonian Journal of Chemistry and Chemical Engineering bisoprolol related substances forced degradation studies |
| title | Development and validation of an analytical method for the determination of related substances in bisoprolol fumarate in dosage forms by HPLC-UV-DAD |
| title_full | Development and validation of an analytical method for the determination of related substances in bisoprolol fumarate in dosage forms by HPLC-UV-DAD |
| title_fullStr | Development and validation of an analytical method for the determination of related substances in bisoprolol fumarate in dosage forms by HPLC-UV-DAD |
| title_full_unstemmed | Development and validation of an analytical method for the determination of related substances in bisoprolol fumarate in dosage forms by HPLC-UV-DAD |
| title_short | Development and validation of an analytical method for the determination of related substances in bisoprolol fumarate in dosage forms by HPLC-UV-DAD |
| title_sort | development and validation of an analytical method for the determination of related substances in bisoprolol fumarate in dosage forms by hplc uv dad |
| topic | bisoprolol related substances forced degradation studies |
| url | https://mjcce.org.mk/index.php/MJCCE/article/view/2430 |
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