Vol. 6, Issue 1, Part A (2024)

Background: The present investigation reported in the thesis was aimed to develop a new method development and validation for the simultaneous estimation of Metformin and Dapagliflozin by RP-HPLC method. Literature reveals that there are no analytical methods reported for the simultaneous estimation Metformin and Dapagliflozin by RP-HPLC method.
Objective: The analytical method for the simultaneous estimation of Metformin and Dapagliflozin will be developed by RP-HPLC method by optimizing the chromatographic conditions.
The developed method is validated according to ICH guidelines for various parameters specified in ICH guidelines, Q2 (R1).
Materials and Methods: The detection wavelength was selected by dissolving the drug in mobile phase to get a concentration of 10µg/ml for individual and mixed standards. The resulting solution was scanned in U.V range from 200-400nm. The overlay spectrum of Metformin and Dapagliflozin was obtained and the isobestic point of Metformin and Dapagliflozin showed absorbance’s maxima at 240 nm.
Results: The chromatographic method development for the simultaneous estimation of Metformin and Dapagliflozin were optimized by several trials for various parameters as different column, flow rate and mobile phase, finally the following chromatographic method was selected for the separation and quantification of Metformin and Dapagliflozin in API and pharmaceutical dosage form by RP-HPLC method.
Conclusion: It can be concluded that the proposed Reverse Phase High Performance Liquid Chromatographic (RPHPLC) method is accurate, precise, sensitive, specific, robust and reproducible for the simultaneous analysis of Metformin and Dapagliflozin. The results are summarized on evaluation of the above results, it can be concluded that the variation in flow rate affected the method significantly. Hence it indicates that the method is robust even by change in the flow rate ±0.2ml/min. The method is robust only in less flow condition.