ABSTRACT:
The investigation described the formulation and validation of a simple, cost-efficient, and reliable UV-spectrophotometric method for estimating Empagliflozin in its pure form and in tablet formulations. Methanol was utilized as the solvent, and the wavelength corresponding to maximum absorbance (?max) was determined to be 225 nm. The method was systematically validated following the guidelines of the International Council for Harmonization (ICH), establishing its applicability for routine use in pharmaceutical laboratories. Linearity was confirmed across a concentration range of 5 to 30 µg/ml, with a strong correlation coefficient (R² = 0.9955), indicating a consistent relationship between drug concentration and absorbance. Method precision was assessed through both intraday and interday studies at concentrations of 10, 20, and 30 µg/ml. The resulting %RSD values were well within the acceptable range, supporting the method’s reproducibility. Accuracy was demonstrated through recovery experiments conducted at 50%, 100%, and 150% levels, with recovery rates consistently falling between 98% and 102%, highlighting the method’s reliability.The assay performed on pharmaceutical tablets confirmed the method's ability to accurately quantify the drug content. Sensitivity studies provided a limit of detection (LOD) of 0.075 µg/ml and a limit of quantification (LOQ) of 0.228 µg/ml. Robustness testing, conducted by introducing small, deliberate variations in experimental parameters such as solvent composition and detection wavelength, showed minimal influence on the results, confirming the method’s stability. In summary, the developed UV-spectrophotometric method proved to be accurate, precise, sensitive, robust, and economically viable, making it highly suitable for the routine quantitative analysis of Empagliflozin in bulk substances as well as in commercial dosage forms.