''METHOD DEVELOPMENT AND VALIDATION OF AN RP-HPLC METHOD FOR DETERMINATION OF ANTIDIABETIC AGENTS IN PHARMACEUTICAL DOSAGE FORM"

Abstract:In this study, a new High-performance liquid chromatographic (RP-HPLC) approach wasdeveloped for the simultaneous measurement of Remogliflozin and Pioglitazone in bulk andtablet dosage form. The method was validated using various parameters such as linearity,accuracy, precision, robustness, LOD, and LOQ. The new approach demonstrated goodlinearity in concentration ranges of 66-330 μg/ml for Remogliflozin and 10-50g/ml forPioglitazone, respectively, with linear regression coefficients (r2= 0.9996 and 0.9995). TheLOD and LOQ for Pioglitazone in were calculated to be 0.55g/ml and 1.674g/ml, respectively,and 2.80g/ml and 8.485g/ml for Remogliflozin. The low % RSD figures imply that theapproach is precise and accurate.The developed RP HPLC method was found to be linear over a wider concentration range, andit can be used for routine qualitative and quantitative analysis of Remogliflozin andPioglitazone in bulk and tablet dosage form and validated according to ICH guidelines. As aresult, the proposed method is easily applicable for routine analysis studies for monitoring theassay in the pharmaceutical industry. In conclusion, the developed RP HPLC approach isreliable, accurate, and precise and can be used for the simultaneous determination ofRemogliflozin and Pioglitazone in bulk and tablet dosage form. The proposed method can be avaluable tool for quality control and routine analysis in the pharmaceutical industry.