Bhaveshkumar Patel,
- Associate Professor Department of Pharmaceutical Analysis, K. B. Institute of Pharmaceutical Education and Research Gujarat India
Abstract
The primary objective of the proposed research was to develop and validate analytical methods for the simultaneous quantification of Alogliptin and Dapagliflozin in a synthetic mixture. Alogliptin and Dapagliflozin are medications used for managing diabetes, with Alogliptin inhibiting the enzyme Dipeptidyl peptidase-4 (DPP-4) and Dapagliflozin belonging to the class of sodium-glucose cotransporter 2 inhibitors (SGLT2 inhibitors). The HPLC method development was conducted using a C18 column (250mm*4.6mm, 5µm particle size). Chromatographic separation was achieved by isocratic mode using a mobile phase consisting of Methanol and 0.1% Ortho-phosphoric acid (pH-3.5 ± 0.01) in the ratio of 95:05 % v/v. The flow rate was maintained at 1 ml/min, and the selected wavelength for estimation was 210 nm. The retention time was determined to be 2.193 min for Alogliptin and 3.901 min for Dapagliflozin. The drugs’ responses showed linear behavior with correlation coefficient values of nearly 0.999 for both Alogliptin and Dapagliflozin over a linearity range of 10 – 60 µg/ml. Recoveries from studies were found to be 99.89% for Alogliptin and 100.06% for Dapagliflozin, indicating high accuracy. The method demonstrated sensitivity with low LOD and LOQ values. The method was validated according to ICH guideline Q2(R1) and was found to be linear, precise, accurate, sensitive, and robust. One significant benefit of the study was the optimization of the mobile phase, which did not require a buffer solution. The proposed research has the potential for quantitative and qualitative analysis of both drugs in synthetic mixtures and will be further utilized for stability studies and the development of bioanalytical methods in biological fluids.
Keywords: Alogliptin, Dapagliflozin, HPLC, Validation, Diabetes.
[This article belongs to Research & Reviews: A Journal of Pharmaceutical Science(rrjops)]
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References
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Research & Reviews: A Journal of Pharmaceutical Science
| Volume | 15 |
| Issue | 02 |
| Received | April 12, 2024 |
| Accepted | May 22, 2024 |
| Published | July 18, 2024 |