Development and Validation of Spectrofluorometric Method for Dapagliflozin Estimation in Bulk & Formulation

Mansi Rana | Pratik Tailor ^[3] | Shailesh Shah

Abstract: Objective: Developed and validated accurate spectrofluorometric method for Dapagliflozin estimation in pharmaceutical dosage form. Method: Dapagliflozin showed good fluorescence intensity in methanol so it was selected as a solvent for estimation of Dapagliflozin. The optimized excitation (?ex) and emission (?em) wavelength were 277 nm and 604 nm respectively. Results: Linear regression analysis data for the calibration plots showed a good linear relationship with R2 0.999 for Dapagliflozin in the concentration range of 2-10 ?g/mL. The repeatability of the method in terms of % RSD was found to be 0.68 %. The intraday and interday precision of the method in terms of %RSD was found to be 0.74-1.34% and 0.75-1.83%, respectively. LOD for Dapagliflozin was found to be 0.15 ?g/mL, while LOQ was found to be 0.46 ?g/mL. %Recovery of Dapagliflozin was found in the range of 99.40-99.76%. The method was successfully applied to pharmaceutical dosage for analysis of Dapagliflozin. The assay result was found to be 99.90%. The developed method was validated in terms of linearity, precision, accuracy, limit of detection and quantification, robustness as per International Conference on Harmonization Q2 (R1) guidelines. Conclusion: This method is rapid, accurate, and simple, making it suitable for routine Dapagliflozin analysis in quality control labs without separation.

Keywords: Spectrofluorimetric, Fluorescence, Excitation, Anti Diabetic and Emission

Edition: Volume 12 Issue 8, August 2023,

Pages: 612 - 617