A New Rp-HPLC Analytical Method Development and Validation for Simultaneous Estimation of Sitagliptin and Etruglifloxin in Bulk and Pharmaceutical Dosage Form

AbstractThe 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 detectand measure the interferences in unknown sample. The sample is a mixture of compoundsinclude solid, liquid, semi solid dosage forms. The quality control of this dosage forms can bedone by using the pharmaceutical analysis. It was plays a major role in qualitative andquantitative analysis of pharmaceutical products. Method validation is the process to confirmthat 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, safetyand efficacy. Analytical method validation is an integral part of the quality control system. Asimple, Accurate, precise method was developed for the simultaneous estimation of theSitagliptin and Ertugliflozin in Tablet dosage form. Retention time of Sitagliptin andErtugliflozin were found to be 2.498 min and 3.105 min. %RSD of the Sitagliptin andErtugliflozin were and 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 fromregression 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. ofErtugliflozin. Retention times were decreased and that run time was decreased, so the methoddeveloped was simple and economical that can be adopted in regular Quality control test inIndustries.