A simple, rapid, precise and accurate stability indicating reverse phase high performance liquid chromatography (HPLC) method was developed for the simultaneous estimation of Metformin and Ertugliflozin. Isocratic separation was achieved on Denali C18 (150 x 4.6 mm, 5 μm) column with mobile phase comprising of 0.01 N KH2PO4: acetonitrile (60:40 V/V), pH adjusted 5.4 with 0.01% ortho phosphoric acid. The flow rate was maintained at 1 mL/min and analytes were screened with UV detector at 224 nm. The method was validated according to ICH guidelines with respect to linearity, accuracy, precision and specificity. The drugs were exposed to various stress conditions like, acid, alkali, oxidation, thermal, UV and neutral and the stressed samples were analysed by the proposed method. No co-eluting, interfering peaks from excipients, impurities were observed during stress conditions and all the degraded peaks are well resolved from parent peaks.

Keywords: Metformin; Ertugliflozin; Validation; HPLC.