UV-Spectrophotometric Method Development and Validation for Quantifying Dapagliflozin in Bulk and Pharmaceutical Formulations

This research focused on establishing a new and highly sensitive UV-spectrophotometric approach for quantifying dapagliflozin in tablet dosage form while ensuring comprehensive validation of analytical parameters following ICH guidelines. The maximum absorbance (λ_max) of dapagliflozin was identified at 220 nm using a UV-Vis spectrophotometer equipped with a 1 cm quartz cell. A stock solution of 1000 μg/ml was prepared using a solvent system consisting of methanol and water in a ratio of 15:85, and subsequent dilutions were performed using distilled water to obtain working solutions. The analytical method adhered to Beer’s Lambert’s law across a concentration range of 5–30 µg/ml, yielding a correlation coefficient of 0.999. Sensitivity parameters included a limit of detection (LOD) of 0.623 µg/ml and a limit of quantification (LOQ) of 1.889 µg/ml. The estimated drug content was approximately 103%, aligning well with the labeled claim of the marketed formulation (Udapa*10). Recovery studies were performed at three different levels, which showed satisfactory results. Furthermore, robustness and ruggedness evaluations showed that the method remained within acceptable limits. Given its simplicity, cost-effectiveness, and reliability, this method is well-suited for routine quantitative assessment of dapagliflozin in bulk and commercial pharmaceutical products.