Abstract

STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION OF BICALUTAMIDE BY UV, FIRST ORDER, AND SECOND ORDER DERIVATIVE SPECTROPHOTOMETERY

D. China Babu*, P. Sravana Sandya, C. Madhusudhana Chetty, Siva Sankar Reddy L.,
T. Venkat Ramaiah, Srinivasareddy N.

Abstract

The present study was an attempt to develop a simple, sensitive, precise, accurate, and low economical method and validated the method for determination of Bicalutamide by UV, First and Second order derivative spectrophotometry. The solvent was used Ethanol and maximum absorbance(λmax) was found to be 272.20nm, 257nm, 228.20nm for UV, first and second order derivative spectrophotometry. Beers law obeyed at the concentration range of 3-11μg/ml, 8-12μg/ml, and 10-18μg/ml for UV, First and Second order derivative spectrophotometry respectively. The correlation coefficient for all the three methods were found to 0.999, and % recovery was found to be 100.05, 99.76 & 99.87% for UV, First and Second order derivative spectrophotometry respectively. The proposed method has been validated as per ICH guidelines for Linearity, Accuracy, Precision, Specificity, LOD, and LOQ. The method was also applied for the degradations studies. The LOD values were found to be 0.04μg/ml, 0.12μg/ml, 0.14μg/ml and LOQ values were found to be 0.13μg/ml, 0.41μg/ml, 0.45μg/ml for UV, First and Second order derivative spectrophotometer respectively. The developedmethod was validated successfully for the estimation of Bicalutamide in bulk and dosage form.

Keywords: UV-Visible spectroscopy, Bicalutamide, Stability studies, UV, First and second order derivative.