Development and Validation of a Novel Stability Indicating UVSpectrophotometric Method for Estimation of Febuxostat in Bulk and Pharmaceutical Formulation (Tablets)

Abstract

Introduction: The present research work involves the development of a simple, economic, accurate, quick and reproducible UV spectrophotometric method for the estimation of Febuxostat in bulk as well as its pharmaceutical formulation i.e. tablets. Materials and Methods: Phosphate buffer pH 6.8 was used for the preparation of stock solution. Different solutions of drug were prepared by diluting the stock solution with the same buffer. Results: Febuxostat was estimated at UV maxima of 312 nm in pH 6.8 phosphate buffer using UV-Visible double beam spectrophotometer. The drug concentration was found to obey Beer’s law over a concentration range of 1–10 μg/ml with line equation y = 0.078x+0.062 and correlation coefficient of 0.999. Results obtained were validated statistically and by recovery study method. Conclusion: The result of analysis was validated according to ICH guidelines and found that the proposed method can be used for quality control of pharmaceutical formulations and routine laboratory analysis.