ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS DETERMINATION OF DAPAGLIFLOZIN AND SITAGLIPTIN IN PURE PHARMACEUTICAL DOSAGE FORM BY RP-HPLC

The objective of this study was to develop a new simple, rapid, sensitive, and validated reversed phase-high performance liquid chromatography (RP-HPLC) method for the simultaneous estimation of Dapagliflozin and sitagliptin in tablet dosage form. By utilizing RP-HPLC, this method fills a gap in the existing literature. Optimizing various parameters of the chromatographic process was key to developing an effective method for separating and detecting drugs. International guidelines and regulatory requirements were followed for the validation of the method, including specificity, linearity, accuracy, Precision, robustness, and suitability for the system. For analysis of mixed solutions containing Dapagliflozin and Sitagliptin, a Chromatographic separation was achieved on a FLOWROSIL C 18 column (150x4.6mm), 5µm, a mobile phase ratio consisting of Buffer: ACN: Methanol (50:50) at flow rate 1.0ml/min, and total run time 10 min, The injection volume 20µl. The detection wavelength is 210nm. Approximately 2000 plates were found, indicating a successful chromatographic separation. With a tailing factor of less than 2 and a well-resolved peak, the peaks appear symmetrical and well-resolved. In order to ensure there were no interfering peaks, retention times for Dapagliflozin and Sitagliptin were found to be 6.897 and 4.584min. As for Dapagliflozin, the correlation coefficient (R²) is 50% and Sitagliptin is 150%. This indicates a good linear relationship between drug concentrations and peak areas based on the high correlation coefficients. For Dapagliflozin and Sitagliptin, the %RSD values were 0.12% and 1.31%, respectively, below the acceptable limit of 2%. As a result, the method is accurate and repeatable. In the study of Dapagliflozin, the mean percent recovery was 98.74%, while in the study of Sitagliptin, the mean percent recovery 98.57%. Under varied conditions, both Dapagliflozin and Sitagliptin showed %RSD values within the Acceptable range of 2%, demonstrating the robustness and reliability of the method. This Study concluded that valuable insight is provided into the use of validated RP-HPLC methods in this study, which contributes significantly to the evolution of pharmaceutical analytical techniques.