METHOD DEVELOPMENT AND VALIDATION OF DAPAGLIFLOZIN IN API BY RP-HPLC AND UV-SPECTROSCOPY
Journal Title: International Journal of Pharmaceutical Sciences and Drug Research - Year 2014, Vol 6, Issue 3
Abstract
In the present study, two analytical methods were developed for the estimation of Dapagliflozin in API. Method A: RP-HPLC method, Method B: UV spectroscopic method. In method A, the drug showed linearity in the range of 25-150µg/ml with a correlation coefficient (r2) of 0.999, where as in method B, the linearity range was found to be 1-5µg/ml with a correlation coefficient of (r2) 0.999. Both the methods were validated for different validation parameters such as linearity, accuracy, precision, detection limit, quantitation limit, robustness and ruggedness and the results were found to be within the acceptance limits as per the guidelines of International Conference on Harmonization (ICH).
Authors and Affiliations
Sanagapati Manasa, Dhanalakshmi K. , Nagarjuna Reddy G, Sreenivasa S.
Keywords
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