Abstract
Analytical method for simultaneous estimation of Ertugliflozin (ERT) and Metformin hydrochloride (MET) was developed and validated by high-performance liquid chromatography (HPLC) as per ICH guidelines. The drugs were injected into the inertsil C18 (250 x 4.6 mm) maintained at room temp and wavelength 220 nm. The mobile phase consists of buffer (potassium dihydrogen pH 4.0) and methanol (65:35 v/v). The flow rate is maintained at 1.0 mL/min. The calibration curve was linear and regression coefficient (R-2) value was found to be 0.999 and concentration ranging from 1.5-4.5 mu g/mL and 100-300 mu g/mL for Ertugliflozin and Metformin hydrochloride respectively. The LOD and LOQ of the method were found 1.04 mu g/mL, 9.61 mu g/mL and 0.0007 mu g/mL, 0.006 mu g/mL for Ertugliflozin and Metformin HCl. The developed method was found to be simple, precise, specific, linear and accurate as validated as per USP and International Conference on Harmonization (ICH) guidelines.