Development and Validation of Stability-indicating RP-HPLC Method for the Simultaneous Estimation of Metformin and Ertugliflozin

A rapid, precise and sensitive RP-HPLC strategy was established for the simultaneous analysis of the Metformin and Ertugliflozin in bulk and tablet dosage form. The evolved methodology used Ascentis 150 (150 mm x 4.6 mm, 5 μ) as column and 0.1% OPA: acetonitrile (60:40) as mobile phase. Temperature of the column at 30 °C and the detection wavelength at 220.0 nm were maintained. The chromatographic responses of Metformin and Ertugliflozin were eluted at 2.267 and 2.803 min, respectively. Validation of the optimized method was done as per the protocols of ICH. Upon utilization of optimum chromatographic conditions, the method showed good linearity for Metformin and Ertugliflozin across the concentration range of 25-150 μg/mL and 0.375-2.25 μg/mL, respectively. The %RSD values in accuracy, precision and robustness studies were observed less than 2.0. The %assay values for both Metformin and Ertugliflozin were found to be within acceptance criteria, when the analytes were estimated in the marketed formulation. The method was also observed to be sensitive. The LOD and LOQ values of Metformin (0.098 and 0.297 μg/mL) and Ertugliflozin (0.001 and 0.004 μg/mL) indicated the same. The method showed less retention times, good linearity, accuracy and robustness. Hence, the developed RP-HPLC methodology can be employed in quality control testing of both metformin and ertugliflozin.