Development and Validation of Analytical Method for Simultaneous Estimation of Dapagliflozin Propanediol Monohydrate and Sitagliptin Phosphate Monohydrate in Tablet Dosage Form

Axita Parmar, Priyanka Patil, Krishna Soni, Dr Chainesh Shah, Dr Umesh Upadhyay

Abstract: In the present study UV spectroscopy methods were developed validated for the simultaneous analysis of dapagliflozin propanediol monohydrate and sitagliptin phosphate monohydrate in tablet dosage form. UV spectroscopy were developed using Q-Absorbance ratio method. From overlay spectra of two drugs, it was evident that DAPA and SITA have an iso-absorptive point at 222.80 nm (?1). The second wavelength used was 266.80 nm (?2) of ?max of SITA. DAPA and SITA showed considerable absorbance at both wavelengths. The methods were validated in terms of linearity, accuracy, precision and robustness. Both the methods were linear (R2= <1) and accurate (In UV method %recovery for DAPA was 99.66-101.45% and for SITA was 100.26-101.76%. The method was also found precise (%RSD <2%) and robust. So, the method was found to be accurate, precise, specific, robust and reproducible.

Keywords: Dapgliflozin, Sitaglptin, UV-spectroscopy, FT-IR, Q-ABSORBANCE ratio