Force degradation studies

A rapid, accurate, linear, and sensitive RP-HPLC method has been developed and validated for estimation of febuxostat in the bulk drug and marketed tablet formulation. The chromatographic separation was achieved on Kromasil C18 Column (250 mm × 4.6 mm, 5 μm particle size) using solvent methanol:water(65 : 35 v/v, pH 3.0 adjusted with OPA)as a mobile phase at flow rate of 1.0 ml/min and25°C column temperature was maintained and analysis were carried out at detection wavelength316 nm. The linearity study was studied in the concentration range 10-50 μg/ml for febuxostat and correlation coefficient was found to be 0.999. The percentage purity of febuxostat was found in the range of 98-101%. The limit of detection and limit of quantification were found to be1.22μg/ml and3.58μg/ml. The method was validated for linearity, precision, accuracy, specificity and selectivity. The obtained results indicates that the proposed method allows selective analysis of febuxostat, in the presence of their degradation products formed under a variety of stress conditions. The developed procedure is also applicable for the determination of instability of the drugs in commercial products.