Abstract

DEVELOPMENT AND VALIDATION OF RP-HPLC 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 RP-HPLC method was developed validated for the simultaneous analysis of Sitagliptin and Danazol in synthetic mixture. RP-HPLC method was developed using Cyber-sil C18 (250 x 4.6mm, 5μm) column as a stationary phase and Acetonitrile: Methanol: Water (60:10:30 % v/v/v) as mobile phase. Flow rate was 1ml/ min at 267 nm. The method was 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) and accurate (% recovery was 99.38% - 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.