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Author(s): Amgoth Krishnamanjari Pawar, Vaddeswaram Ashok Babu, Uppada Harini, Sindhe Divya Sree

Objective: A simple and precise reversed-phase high-performance liquid chromatography method was developed and validated for the simultaneous determination of metformin (MET) hydrochloride and dapagliflozin (DAP) in bulk and pharmaceutical dosage form. Methods: Chromatography was carried out on Unisol C18 (150 mm × 4.6 mm, 3 μ particle size) column containing mobile phase of Methanol: Buffer (Triethanolamine adjusted to pH 3.5 with orthophosphoric acid in the ratio of 80:20 %/v/v) at a flow rate of 0.8 ml/minute. The analyte was monitored using photodiode array detector at 245 nm. Results: The retention time was found to be 2.040 minutes and 3.733 minutes for DAP and MET hydrochloride, respectively. The proposed method was found to be having linearity in the concentration range of 20-120 μg/ml for MET (R2= 0.9988) and 10-60 μg/ml for DAP (R2= 0.9989), respectively. The mean % recoveries obtained were found to be 99.47-100.21 % for MET and 98.2-99.9 % for DAP respectively. The method developed has been statistically validated according to ICH guidelines. Conclusion: Hence the optimized method can be successfully applied for the simultaneous determination of Metformin hydrochloride and Dapagliflozin in the routine quality control analysis.

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