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Original Articles Open Access
A simple and precise stability indicating RP-HPLC method was developed and validated for the simultaneous determination of Metformin Hydrochloride and Saxagliptin in pure drug and combined tablet dosage form. Chromatography was carried out on Hypersil ODS C18 (250x4.6mm, 5μ particle size) analytical column using a mobile phase of Phosphate buffer (KH2PO4) adjusted to pH 5.0 with dilute orthophosphoric acid, acetonitrile and methanol in the ratio of 25:50:25 % v/v/v at a flow rate of 1.0 ml/min. The analyte was monitored using PDA detector at 211 nm. The retention time was found to be 2.246 min and 4.516 min for Metformin Hydrochloride and Saxagliptin respectively. Linearity was observed in the concentration range of 125-750 μg/ml and 1.25-7.5 μg/ml for both Metformin Hydrochloride and Saxagliptin with correlation coefficient of 0.999 respectively. The mean % recoveries obtained for Metformin Hydrochloride and Saxagliptin were found to be 99.62-99.93% and 99.66- 99.80% respectively. Stress testing which covered acid hydrolysis, base hydrolysis, peroxide, photolytic (UV light), neutral and thermal degradation was performed to prove the specificity of the proposed method and degradation was achieved. The developed method has been statistically validated according to ICH guide lines and found to be simple, precise and accurate with the prescribed values. Thus the proposed RP-HPLC method was successfully applied for the stability indicating simultaneous estimation of Metformin Hydrochloride and Saxagliptin in routine quality control analysis in bulk and marketed formulations.
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Author(s): Mohammad Yunoos and D Gowri Sankar
Metformin Hydrochloride, Saxagliptin, RP-HPLC, Forced degradation, Method validation.