Stability indicating eco-friendly HPLC method development and validation for the estimation of bisoprolol fumarate and telmisartan
Abstract Background Telmisartan and bisoprolol fumarate together are two medications that diminish arterial pressure. The current study comprises an evaluation of the proposed methodology's greenness regarding the HPLC method used to govern the medication mixture regardless of dose form A novel...
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SpringerOpen
2025-01-01
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| Series: | Future Journal of Pharmaceutical Sciences |
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| Online Access: | https://doi.org/10.1186/s43094-025-00760-3 |
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| author | Hitanshi Darji Pratima Prajapati Zarna Dedania Ronak Dedania |
| author_facet | Hitanshi Darji Pratima Prajapati Zarna Dedania Ronak Dedania |
| author_sort | Hitanshi Darji |
| collection | DOAJ |
| description | Abstract Background Telmisartan and bisoprolol fumarate together are two medications that diminish arterial pressure. The current study comprises an evaluation of the proposed methodology's greenness regarding the HPLC method used to govern the medication mixture regardless of dose form A novel stability suggesting HPLC method's environmental effect was evaluated using the greenness metrics. Stress conditions comprising acidic, alkaline, oxidative, thermal, and photolytic degradation were applied for both of the medications. Results The RP—HPLC method employing a reversed-phase C18 column with a gradient approach, the HPLC chromatography was carried out. The mobile phase consisted of acetonitrile, methanol, and phosphate buffer (60:35:5, %v/v/v), with the stationary phase being the Unisphere C18 column Agela Tech. The RP-HPLC method uses UV detection at 224 nm with chromatographic purification spanning linearities of 2.5–12.5 μg/mL for bisoprolol fumarate and 40.0–200.0 μg/mL for telmisartan, correspondingly. The procedure is accurate and precise, as demonstrated by an outcome that % RSD inside the permissible range. Additionally, various stressors were introduced to the medications. The approach's green credentials with respect to solvent utilization, chemical substances, expenditure of energy, and waste formation have been verified by the greenness data collected during the evaluation. No chromatographic or spectrum impediments caused by formulation additives have been observed. Conclusion Bisoprolol fumarate and telmisartan could be measured simultaneously using the devised RP-HPLC method, which was simple, quick, sensitive, accurate, precise, linear, and stability indicating. The proposed approach showed ecological friendliness, robustness, sensitivity, and ease of use. As a result, the devised method could be applied to the regular quality checking of tablets and bulk medications. |
| format | Article |
| id | doaj-art-61c6f491d4924edfa4bb46533c1ff5aa |
| institution | Kabale University |
| issn | 2314-7253 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | SpringerOpen |
| record_format | Article |
| series | Future Journal of Pharmaceutical Sciences |
| spelling | doaj-art-61c6f491d4924edfa4bb46533c1ff5aa2025-01-19T12:13:05ZengSpringerOpenFuture Journal of Pharmaceutical Sciences2314-72532025-01-0111111310.1186/s43094-025-00760-3Stability indicating eco-friendly HPLC method development and validation for the estimation of bisoprolol fumarate and telmisartanHitanshi Darji0Pratima Prajapati1Zarna Dedania2Ronak Dedania3Department of Pharmaceutical Science, Bhagwan Mahavir College of Pharmacy, Bhagwan Mahavir UniversityDepartment of Pharmaceutical Science, Bhagwan Mahavir College of Pharmacy, Bhagwan Mahavir UniversityBhagwan Mahavir College of Pharmacy, Bhagwan Mahavir UniversityBhagwan Mahavir College of Pharmacy, Bhagwan Mahavir UniversityAbstract Background Telmisartan and bisoprolol fumarate together are two medications that diminish arterial pressure. The current study comprises an evaluation of the proposed methodology's greenness regarding the HPLC method used to govern the medication mixture regardless of dose form A novel stability suggesting HPLC method's environmental effect was evaluated using the greenness metrics. Stress conditions comprising acidic, alkaline, oxidative, thermal, and photolytic degradation were applied for both of the medications. Results The RP—HPLC method employing a reversed-phase C18 column with a gradient approach, the HPLC chromatography was carried out. The mobile phase consisted of acetonitrile, methanol, and phosphate buffer (60:35:5, %v/v/v), with the stationary phase being the Unisphere C18 column Agela Tech. The RP-HPLC method uses UV detection at 224 nm with chromatographic purification spanning linearities of 2.5–12.5 μg/mL for bisoprolol fumarate and 40.0–200.0 μg/mL for telmisartan, correspondingly. The procedure is accurate and precise, as demonstrated by an outcome that % RSD inside the permissible range. Additionally, various stressors were introduced to the medications. The approach's green credentials with respect to solvent utilization, chemical substances, expenditure of energy, and waste formation have been verified by the greenness data collected during the evaluation. No chromatographic or spectrum impediments caused by formulation additives have been observed. Conclusion Bisoprolol fumarate and telmisartan could be measured simultaneously using the devised RP-HPLC method, which was simple, quick, sensitive, accurate, precise, linear, and stability indicating. The proposed approach showed ecological friendliness, robustness, sensitivity, and ease of use. As a result, the devised method could be applied to the regular quality checking of tablets and bulk medications.https://doi.org/10.1186/s43094-025-00760-3Bisoprolol fumarateTelmisartanMethod validationStability studyHPLC methodGreenness assessment |
| spellingShingle | Hitanshi Darji Pratima Prajapati Zarna Dedania Ronak Dedania Stability indicating eco-friendly HPLC method development and validation for the estimation of bisoprolol fumarate and telmisartan Future Journal of Pharmaceutical Sciences Bisoprolol fumarate Telmisartan Method validation Stability study HPLC method Greenness assessment |
| title | Stability indicating eco-friendly HPLC method development and validation for the estimation of bisoprolol fumarate and telmisartan |
| title_full | Stability indicating eco-friendly HPLC method development and validation for the estimation of bisoprolol fumarate and telmisartan |
| title_fullStr | Stability indicating eco-friendly HPLC method development and validation for the estimation of bisoprolol fumarate and telmisartan |
| title_full_unstemmed | Stability indicating eco-friendly HPLC method development and validation for the estimation of bisoprolol fumarate and telmisartan |
| title_short | Stability indicating eco-friendly HPLC method development and validation for the estimation of bisoprolol fumarate and telmisartan |
| title_sort | stability indicating eco friendly hplc method development and validation for the estimation of bisoprolol fumarate and telmisartan |
| topic | Bisoprolol fumarate Telmisartan Method validation Stability study HPLC method Greenness assessment |
| url | https://doi.org/10.1186/s43094-025-00760-3 |
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