Eco-Friendly First-Derivative UV-Spectrophotometric Method for Simultaneous Estimation of Dapagliflozin and Eplerenone in Bulk and Synthetic Mixture

Background: Dapagliflozin and Eplerenone are commonly used together for the management of diabetes-related cardiovascular and renal disorders, necessitating a reliable analytical approach for their combined analysis. Objective: The present work describes the development and validation of an environmentally benign first-order derivative UV-spectrophotometric method for the simultaneous determination of Dapagliflozin and Eplerenone in a synthetic mixture, in accordance with ICH Q2(R2) guidelines. Methods: First-order derivative spectra were employed to resolve spectral overlap between the two drugs. Dapagliflozin exhibited a zero-crossing point at 232 nm, while Eplerenone showed a zero-crossing at 254 nm, enabling selective quantification without mutual interference. Results: The method demonstrated linearity over concentration ranges of 1–6 µg/mL for Dapagliflozin and 2.5–15 µg/mL for Eplerenone, with correlation coefficients approaching unity. Validation studies confirmed acceptable precision, accuracy, specificity, robustness, and sensitivity. No interference from excipients was observed, and the limits of detection and quantification were suitable for routine analysis. Conclusion: Overall, the proposed method is simple, accurate, cost-effective, and eco-friendly, making it suitable for routine quality control of pharmaceutical preparations containing these drugs.