Simultaneous Method Development and Validation of UVSpectroscopic Method for the Estimation of Empagliflozin and Sitagliptin in Bulk DosageForm

Abstract

Two simple, Precise and economical UV spectrophotometric methods have been developed for the Simultaneous estimation of Empagliflozin and Sitagliptin in bulk and Pharmaceutical dosage forms. Method A is simultaneous equation method (Vierodt’s Method), which is based on measurement of absorption at 224nm and 267nm i.e.λmax of Empagliflozin and sitagliptin respectively. Method B is Absorbance ratio (Q analysis method) which is based on measurement of absorption at wavelength of 233nm and 265nm i.e. iso absorptive point of Empagliflozin and sitagliptin and λmax of Empagliflozin respectively. Linearity was observed in the concentration range of 5-25µg/ml for Empagliflozin and 5-25µg/ml for sitagliptin. The accuracy of methods was assessed by recovery studies and was found to be within range of 98.97-102.14% for both Empagliflozin and sitagliptin. The developed methods were validated with respect to linearity, accuracy (recovery), and precision. The results were validated statistically as per ICH Q2 R1 guideline and results were found to be satisfactory.