SIMULTANEOUS ESTIMATION OF DAPAGLIFOZIN AND SAXAGLIPTIN IN TABLETS USING TWO CHEMOMETRIC-ASSISTED UV-SPECTROPHOTOMETRIC METHODS

摘要

Two simple, accurate, precise and economical UV spectrophotometric methods, Multiple Linear Regression (MLR) and Principal Component Regression (PCR), were developed for the simultaneous estimation of dapaglifozin (DAPA) and saxagliptin (SAXA) in tablets. Beer's law was obeyed in the concentration ranges of 10-50 ug/mL for DAPA and 5-25 ug/mL for SAXA. Synthetic mixtures containing two drugs were prepared to build the training set and validation set in the calibration range using D-optimal mixture design in phosphate buffer pH 6.8 and were recorded at six wavelengths in the range of 230 - 215 nm at intervals of AX = 3 nm. Both methods were validated as per ICH guidelines with respect to the accuracy and precision and found suitable for routine analysis of tablets containing DAPA and SAXA without separation.