RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF METFORMIN HCL AND CANAGLIFLOZIN IN PHARMACEUTICAL FORMULATION

Abstract

A simple, specific, accurate, precise and stability-indicating RP-HPLC method was developed and validated for the simultaneous estimation of metformin HCl and canagliflozin in pharmaceutical formulation. The method was developed using the Altima C8 column (150 ×4.6 mm, 0.5 μm) with a mobile phase consisting of acetonitrile and 0.1 % orthophosphoric acid in water (62:38 %V/V) with a flow rate of 1 mL/min. Detection was carried out at 254 nm using a PDA detector. The retention time for metformin HCl and canagliflozin was found to be 2.282 and 3.339 min, respectively. The proposed method was validated for linearity, range, accuracy, precision, robustness, LOD and LOQ. Linearity was observed over a concentration range 15-225 μg/mL for metformin HCl (r2 =0.9995) and 5-40 μg/mL for canagliflozin (r2 =0.9988). The % RSD for intraday and interday precision was found to be 0.13 and 0.20 for metformin HCl and 0.18 and 0.20 for canagliflozin. The LOD and LOQ were found to be 0.16 μg/mL and 0.54 μg/mL for metformin HCl and LOD and LOQ were found to be 0.05 and 0.21 μg/mL for canagliflozin. Metformin HCl and canagliflozin were subjected to stress conditions of degradation including acidic, alkaline, oxidative, thermal and photolysis.