Recent Progress in Analytical Method Development and Validation of Dapagliflozin

Review Article

Abstract

Recent advances in analytical methodology for dapagliflozin quantification have highlighted various instrumental approaches crucial for pharmaceutical quality control. Dapagliflozin, a sodium-glucose co-transporter-2 inhibitor, requires precise analytical methods for its determination in pharmaceutical formulations. Multiple validated techniques including UV spectrophotometry, reversed-phase high-performance liquid chromatography (RP-HPLC), and high-performance thin-layer chromatography (HPTLC) have emerged for analyzing dapagliflozin alone and in combination with other antidiabetic agents. UV spectrophotometric methods demonstrate simplicity and cost-effectiveness, utilizing various solvents and detecting wavelengths between 210-280 nm. RP-HPLC methods employ C18 columns with diverse mobile phase compositions, achieving efficient separation with retention times typically under 6 minutes. Method validation parameters encompass linearity, precision, accuracy, specificity, and robustness following International Conference on Harmonisation (ICH) guidelines. Reported linear ranges vary from 5-100 μg/mL for UV methods and 10-250 μg/mL for HPLC methods, with correlation coefficients exceeding 0.99. Recovery studies indicate accuracies between 98-102%, while precision studies show relative standard deviations below 2%. Several stability-indicating assays confirm method selectivity and ability to detect degradation products.