STABILITY INDICATING RP-UPLC-DAD METHOD FOR DETERMINATION OF METFORMIN AND CANAGLIFLOZIN IN BULK AND TABLET DOSAGE FORM

The objective of the present work is to develop and validate a novel stability-indicating RP-UPLC-DAD method for the simultaneous analysis of Metformin and Canagliflozin in bulk and tablet dosage form. The chromatographic separation was accomplished on a Waters UPLC system equipped with autosampler and PDA detector. A volume of 5 µL of sample or standard was injected into the column and the analytes were separated by using the mobile phase containing mixture of 0.1% orthophosphoric acid buffer (pH adjusted to 3.0 with 0.1 N NaOH) and acetonitrile in the ratio 30:70% v/v at a flow rate of 0.25ml/min through C18 BEH (Ethylene Bridged Hybrid) UPLC (100 mm × 2.1 mm 1.7 µm) at 55 °C column temperature and the detector wavelength was set at 260 nm. Peak area and retention time of Metformin and Canagliflozin were found to be 651341 & 332544, 0.994 & 1.508 respectively. Regression analysis shows r value greater than 0.999 for Metformin and Canagliflozin. Percent recovery of Metformin and Canagliflozin was found to be 99.94 %-100.16% & 100.17%-100.68%, respectively. The developed RP-UPLC method was validated with regard to system suitability, linearity, robustness, accuracy, precision, LOD, LOQ and forced degradation studies.