Abstract

DEVELOPMENT AND VALIDATION OF UV SPECTROSCOPY METHOD FOR SIMULTANEOUS ESTIMATION OF SITAGLIPTIN AND DANAZOL IN SYNTHETIC MIXTURE

Ayushi Patel*, Prof. Priyanka Malani and Dr. U. M. Updhayay

ABSTRACT

In the present study UV-spectroscopy was developed validated for the simultaneous analysis of Sitagliptin and Danazol in synthetic mixture. UV spectroscopy was developed using First Order Derivative Spectroscopy method. The zero-crossing point (ZCP) was obtained at 232.2 nm and 303.68 nm for estimation of DAN and SIT respectively. The methods were validated in terms of linearity, accuracy (% Recovery), precision (inter day, intraday and reproducibility) and robustness as per ICH Q2 (R1) Guidelines. The method was linear (R2 = 0.998-0.999) and accurate (% recovery was 99.08% - 101.57%). The method was also found precise (% RSD< 2%) and robust. So. It was found to be accurate, precise, specific, selective, repeatable, robust and reproducible.

Keywords: Sitagliptin, Danazol, RP-HPLC methods, development, Validation.