Development and Validation of Dapagliflozin by Reversed-Phase High-Performance Liquid Chromatography Method and It’s Forced Degradation Studies

Abstract

Objective: To develop and validate a simple, selective, precise, and accurate method for the estimation of dapagliflozin using reversed-phase highperformance liquid chromatography (RP-HPLC) technique in bulk and tablet formulation. Methods:The proposed method utilizes chromatographic conditions hypersil BDS (250 mm × 4.6 mm, 5 µ), mobile phase was buffer:acetonitrile (60:40) ratio, flow rate was maintained 1 ml/minute, column temperature was set at 30°C, detection wave length was 245 nm, and diluent was mobile phase.Results: By injecting 5 times of the standard solution system suitability parameters were studied, and results were found well under the acceptance criteria. The linearity study was performed by taking 25-150% levels, and the R 2 value was found to be 0.999, precision was found to be 0.5 for repeatability and 0.31 for intermediate precision. The % recovery was found to be 99.89%. Limit of detection and limit of quantitation were found to be 0.60 µg/ml and 1.81 µg/ml, respectively. The % purity was found to be 99.71%. Degradation study on dapagliflozin was performed and concluded that the purity threshold was more than purity angle and within the acceptable range. Conclusion:The developed RP-HPLC method for dapagliflozin was found to be simple, precise, accurate, reproducible, and cost effective. Statistical analysis of the developed method conforms that the proposed method is an appropriate and it can be useful for the routine analysis. This method gives the basic idea to the researcher who is working in area such as product development and finish product testing.