Analytical Method Development and Validation of Drospirenone by UV-Vis Spectroscopy in Accordance with ICH Guidelines

This study presents the development and validation of a UV-Visible spectrophotometric method for the estimation of Drospirenone in pharmaceutical formulations. Drospirenone, a synthetic progestin, was found to be freely soluble in ethanol, which was selected as the solvent due to its green chemistry profile. The absorption maximum (λmax) was observed at 274 nm. A linear calibration curve was established over the concentration range of 3–15 µg/mL, exhibiting excellent linearity with a correlation coefficient (r²) of 0.9999. The method demonstrated high sensitivity, with a limit of detection (LOD) of 0.363 µg/mL and a limit of quantification (LOQ) of 1.04 µg/mL. Precision studies at 6 µg/mL showed a %RSD of 1.73%, confirming method repeatability. Accuracy was validated via recovery studies at 80%, 100%, and 120% levels, yielding recoveries between 99.28% and 102.11%. Robustness was tested by varying ethanol-water ratios, showing minimal impact on results (%RSD < 1%). The method complies with ICH Q2(R1) guidelines, offering a simple, accurate, precise, and robust approach for routine quality control of Drospirenone in tablet dosage forms.