RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF ERTUGLIFLIZIN AND SIGLIPTIN IN BULK AND DOSAGE FORM

Abstract

Several spectrophotometric and HPLC methods have been reported for determination of Ertugliflozin and Sitagliptin in drugs and in pharmaceutical dosage forms. Hence, in the present study, a new, sensitive, suitable and robust reversed-phase high performance liquid chromatography method was developed and validated for the determination of Ertugliflozin and Sitagliptin in bulk drug and in tablet formulation. In RP-HPLC method, Methanol and Water (75:25 % v/v) was used as mobile phase, at a flow rate of 1.0 ml/min, on HPLC system containing UV- detector with Openlab EZchrome software and Kromasil C18, 250 mm X 4.6 mm, 5 µm. The detection was carried out at 258 nm. The method gave suitable retention time i.e. 3.60 min for Ertugliflozin and Sitagliptin. The results of analysis in the method were validated in terms of Filter study, Solution stability, specificity, Linearity, accuracy, precision (Repeatability and intermediate precision), limit of detection, limit of quantification and robustness. A simple and precise method was developed for the assay of Ertugliflozin and Sitagliptin in bulk drug and in tablet formulation.