Degradation Behavior and Kinetic Study of Febuxostat

Abstract

A SFC method for Stability indicating assay was developed and validated. The separation was accomplished on column Cyno SB-CN (250 mm X 4.6 mm), 5 M, column under isocratic mode. The optimized mobile phase was CO2 1.2 ml/min with Methanol (12.5%) as modifier. The detection wavelength was 315 nm. The method is validated as per ICH Guideline Q2 (R1) for specificity, linearity, accuracy, precision, robustness, system suitability and solution stability. The linear regression analysis data for the calibration plots showed good linear relationship with concentration range of 50-250 μg/ml for assay determination. The developed method was simple, specific, accurate and precise. Thus the developed method can also be applicable to the routine analysis of febuxostat in marketed formulations. Degradation kinetic study was carried out on HPLC as per ICH Q1A (R2). The Separation was accomplished on column Phenomenex Gemini (250 mm X 4.6 mm), 5 M. The optimized Mobile phase was Acetonitrile:Water (0.1% GAA and 0.1%NH3) with pH 4.35. The developed method was Able to separate drug from degradation product and can be used for kinetic analysis of febuxostat.