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A Novel, Simultaneous stability indicating RP-HPLC method was developed for combined estimation of Metformin Hydrochloride (CANA) and Canagliflozin (MET) in fixed dose pharmaceutical formulations. The developed chromatographic method for the separations of CANA and MET and its degradation products by the use of stationary phase BEH C18 column, 50×2.1 mm, 1.7 μm column with mobile phase consisting of sodium dihydrogen phosphate buffer (30 mM) and10mM of 1-Octane Sulphonic acid in 1000ml of water in mobile phase A, mobile phase B mixture of Methanol: Acetonitrile 50:50 v/v ratio at a flow rate of 0.3 mL/min, with reproducible gradient program. Chromatographic separations was made of analytical peaks and degradation peaks occurring within 10 min. Detection of the analytes Metformin at 230 nm& Canagliflozin at 290 nm using PDA detector. Method validation was performed as per ICH guidelines. Linearity of the method was established from 2–170 μg/ml for Metformin hydrochloride and 12– 180μg/ml for Canagliflozin (R20.999). The method can be considered as stability-indicating and can be used for simultaneous determination of CANA and MET in fixed dose pharmaceutical formulations and drug product stability studies.

A NOVEL SIMULTANEOUS STABILITY-INDICATING UPLC ASSAY METHOD FOR METFORMIN HYDROCHLORIDE AND CANAGLIFLOZIN IN ORAL SOLID DOSAGE FORM