Development and Validation of Simultaneous Equation Method for Estimation of Sitagliptin Phosphate and Empagliflozin in bulk form by UV Spectroscopy

Abstract

For multicomponent pharmaceutical dosage forms, simultaneous equation method has emerged out as boon with lots of advantages like easy, rapid and sensitive method. In this study, a UV spectroscopic method has been established and authenticated for simultaneous estimation of Sitagliptin phosphate and Empagliflozin in bulk form. Methanol: Water (5:5) has been employed as common solvent for the proposed method. The optimum conditions for analysis of the drug were established. Sitagliptin phosphate and empagliflozin showed maximum absorbance (ʎmax) at 267nm and 276.2nm respectively. The calibration plot was found to be linear in the range of 50-250µg/ml for sitagliptin phosphate and empagliflozin with R2= 0.9957 and 0.9981 respectively. Method was validated according to ICH guidelines for linearity, accuracy, precision, system suitability, robustness, sensitivity and specificity. The proposed method was simple, precise, sensitive, accurate, rapid and suitable for routine quality analysis of sitagliptin phosphate and empagliflozin in bulk.