Development and Validation of UV-Spectrophotometric Techniques Using Zero-order, Derivative, and AUC Approaches to Determine Dapagliflozin in Plasma

Objective: To develop and validate a novel, sensitive, and precise UV spectrophotometric method for quantifying dapagliflozin in plasma. Method: Four UV spectroscopic approaches zero-order (Method-A), first-order derivative (Method-B), second-order derivative (Method-C) and AUC were employed by utilizing a protein precipitation technique, with distilled water selected as the optimal solvent. Results: The linearity range to all four methods is 5-25ug/ml. The λmax and r2 for all methods were, Method A (zero-order, λmax = 278 nm, r² = 0.996), Method B (first-order derivative, λmax = 278 nm, r² = 0.9963), Method C (second-order derivative, λmax = 239 nm, r² = 0.9951), and Method D (area under the curve (AUC), λmax = 268–288 nm, r² = 0.9945). The method demonstrated excellent precision, robustness (% RSD < 2), and recovery rates ranging from 98% to 102%, including quantification limits (LOQ) and detection limits (LOD) were established. Conclusion: All four validated methods met ICH criteria, confirming the method’s suitability for routine quality control and bioanalytical analysis of dapagliflozin in both pure and pharmaceutical dosage forms.