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
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
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.