Abstract

“DEVELOPMENT AND VALIDATION OF UV SPECTROSCOPIC ASSAY METHOD OF FEBUXOSTAT IN BULK AND DOSAGE FORM.”

Avinash M. Bhagwat*, Anand P. Khadke, Anuradha M. Patil, Karishma J. Baid, Rucha J. Kulkarni and Nilam S. Shelar

Abstract

A simple and cost effective uv spectrophotometric method is discribed for the determination of febuxostat in bulk drug and in pharmaceutical formulation. The drug was soluble in 0.1N KOH so it was selected as the solvent system for the drug. This insure adequate drug solubility and maximum assay sensitivity. The linearity range for febuxostat at its wavelength of detection of 287nm was obtained as 2-10μg/ml. The linear regression equation obtained by least square regression method, were, Y=0.005x+0.01,where Y is the absorbance and X is the concentration(in μg/ml) of pure drug solution. The absorbance was found to increase linearly with increasing concentration of febuxostat, showing correlation coefficient value of 1. The validity of the described procedure was assessed. Statistical analysis of the result shows high accuracy and good precision. The proposed method was successfully applied to the determination of febuxostat in pharmaceutical formulations without any interference from common excipients. The proposed method was validated as per the ICH guidelines for linearity, accuracy, precision and robustness. This method can be employed for routine quality control analysis of febuxostat in tablet dosage forms. This method can be used for bioanalysis of febuxostat.

Keywords: UV spectroscopy, Febuxostat, ICH guidelines.