A NEW RP-HPLC ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF SITAGLIPTIN AND ERTUGLIFLOZIN IN BULK AND PHARMACEUTICAL DOSAGE FORM

Abstract

The pharmaceutical analysis is as the branch of chemistry it deals with the resolution, 
separation, identification, determination, isolation and purification of a unknown sample. Used to detect and measure the interferences in unknown sample. The sample is a mixture of compounds including solid, liquid, and semi solid dosage forms. The quality control of these dosage forms can be done by using pharmaceutical analysis. It plays a major role in qualitative and quantitative analysis of pharmaceutical products. Method validation is the process to confirm that the analytical procedure employed for a specific test is suitable for its intended use. Analytical testing of a pharmaceutical product is necessary to ensure its purity, stability, safety and efficacy. Analytical method validation is an integral part of the 
quality control system. A simple, Accurate, precise method was developed for the 
simultaneous estimation of the Sitagliptin and Ertugliflozin in Tablet dosage form. 
Retention time of Sitagliptin and Ertugliflozin were found to be 2.498 min and 3.105 min. %RSD of the Sitagliptin and Ertugliflozin were found to be 0.2 and 0.7 respectively. %Recovery was obtained as 99.46% and 99.52% for Sitagliptin and Ertugliflozin respectively. LOD, LOQ values obtained from regression equations of Sitagliptin and Ertugliflozin were 0.48, 1.46 and 0.20, 0.61 respectively. Regression equation of Sitagliptin is y = 9444.x + 1985., and y = 18841x + 1550. of Ertugliflozin. Retention times decreased and that run time was decreased, so the method developed was simple and economical that can be adopted in regular Quality control test in Industries.