DISSOLUTION METHOD DEVELOPMENT AND VALIDATION OF EPLERENONE TABLETS BY UV SPECTROPHOTOMETRY

The article aims at developing simple dissolution method for Eplerenone immediate release tablets by UV spectroscopy and validate as per ICH guidelines. The optimized dissolution method includes 0.1N HCl as dissolution media, apparatus as USP Type 2 Paddle, rpm as 100, temperature of dissolution media as 37±0.5ºC, dissolution volume as 500ml, dissolution time point as 1 hour, working concentration of standard and sample as 10?g/ml and a detection wavelength of 245 nm.The developed method resulted in Eplerenone exhibiting linearity in the range 2.5-20μg/ml. System precision and intra-day precision are exemplified by relative standard deviation of 0.695% and 0.933% respectively. Method was found to be rugged/inter day precise as %RSD was found to be 1.507%. Percentage Mean recovery was found to be in the range of 90-110 % by absolute method during accuracy studies. Hence it can be concluded that effective dissolution method by UV spectroscopy is developed and validated which can be applicable in various pharmaceutical industries. Keywords: Eplerenone, Dissolution method, UV, Validation.