A RAPID ASSAY METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF EPLERENONE IN TABLETS BY UV SPECTROPHOTOMETRY

摘要

Objective: To develop a rapid, simple and a cheap UV spectrophotometric assay method for the estimation of Eplerenone in tablets and validate as per ICH guidelines. Methods: The optimized method uses 0.05N HCl as a solvent for the estimation of assay of Eplerenone in tablets at a detection wavelength of 245 nm. Results: System precision and intra-day precision are exemplified by relative standard deviation of 1.5% and 1.3% respectively. Method was found to be rugged as precision was found to be 1.2%. The developed method resulted in Eplerenone exhibiting linearity in the range 5-15μg/ml. Percentage Mean recovery was found to be in the range of 98‐102, during accuracy studies. Conclusion: A rapid, simple and a cheap UV spectrophotometric assay method was developed and validated for the estimation of Eplerenone in tablets as per ICH guidelines and hence it can be used for the routine analysis in various pharmaceutical industries. Keywords: UV, Eplerenone, Method development, Validation.