Abstract
Objective: A simple, rapid, precise and accurate RP-HPLC stability indicating method was developed and validated for the estimation of Febuxostat in bulk drug and marketed tablet formulation. Methods: The chromatographic separation was achieved on Agilent C18 (250 x 4.6 mm, 5 μm) using solvent 15 mM ammonium acetate buffer (pH 4.8) and acetonitrile (30:70 v/v) as a mobile phase at flow rate of 1 mL/min and ambient column temperature analysis were carried out at detection wavelength of 315 nm. Result: The method was validated for linearity, precision, accuracy, specificity, LOD and LOQ, and robustness. The linearity was studied in the concentration range of 5-25 μg/mL and correlation coefficient was found to be 0.999. The limit of detection and the limit of quantitation were found to be 0.37 μg/mL and 1.13 μg/mL. Febuxostat was subjected to stress conditions of degradation, including acidic, alkaline, oxidation, photolytic and thermal degradation. Febuxostat is more sensitive toward acidic condition than oxidation and less sensitive towards alkaline, thermal and photolytic degradation. Conclusion: The method is simple, reliable, sensitive and precise, which could separate the drug and their degraded product formed under various stress conditions; thus it can be employed as stability-indicating method for the determination of FBX in bulk and pharmaceutical dosage form.
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