Fluorescence spectroscopy for determination of dapagliflozin in pure form and its tablets formulation; Application to content uniformity testing.

Spectrochim Acta A Mol Biomol Spectrosc

Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Tanta University, Egypt.

Published: November 2020

A new, valid method was developed for quantitative spectrofluorimetric analysis of dapagliflozin (DGF) in its pure form and its commercially available tablets (Farxiga®). The proposed analytical method based on measurement of fluorescence intensity for DGF at 303 nm after excitation at 278 nm. Various experimental parameters influencing the fluorescence of DGF were examined to produce the optimal conditions. DGF was successively assayed in concentration range of (100-1000 ng mL) with lower detection limit (LOD) of 26.49 and quantitation limit (LOQ) was 79.48 ng mL. The suggested method was validated according to ICH guidelines for the estimation of DGF in its pure form and its new dosage form with percent recovery of 100.43 ± 1.15. The proposed method was adapted to examine DGF in content uniformity testing according to United States Pharmacopeia guidelines. This method can be used in routine analysis of DGF in quality control lab.

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http://dx.doi.org/10.1016/j.saa.2020.118642DOI Listing

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