Abstract A simple, rapid, specific, accurate and precise reverse phase high performance liquid chromatographic method was developed for the simultaneous estimation of Metformin and Dapagliflozin in tablet dosage form. An Inertsil ODS C18 column having 150 x 4.6mm id in Isocratic mode with mobile phase containing Acetonitrile : phosphate buffer (70:30 %v/v pH: 3.0) was used. The flow rate was 1.0ml/min and effluents were monitored at 240nm.) The retention time of Metformin and Dapagliflozin was 2.463min and 3.760min respectively. The concentration curves of Metformin and Dapagliflozin were linear in the concentration range of 50µg/ml-250 µg/ml and 5µg/ml-25µg/ml of Metformin and Dapagliflozin respectively. The developed method was validated for specificity, precision, linearity, accuracy, LOD, LOQ, robustness. Recovery of Metformin and Dapagliflozin in formulations was found to be in the range of 97.0% -98.0% and 100%-103% respectively confirms the non-interferences of the excipients in the formulation. Due to its simplicity, rapidness and high precision, the proposed HPLC method may be used for the simultaneous determination of these two drugs in pharmaceutical dosage forms.
Keywords: RP-HPLC; Metformin and Dapagliflozin.