A Stability Indicating RP-UPLC Method for Estimation of Febuxostat and its Impurities in Bulk Drugs and Pharmaceutical Dosage forms

This study is aimed at Developing and validating an UPLC method for febuxostat and its related substances that might coexist in bulk drugs and its tablet formulations as impurities that may originate from synthesis process or degradation. A chromatographic system consisting Waters Acquity UPLC HSS C18 (1.8 µm) column, mobile phase of  ammonium acetate with pH 4.5 as Buffer phase and Acetonitrile: Methanol in 1:1 ratio as organic phase, with gradient elution at flow of 0.4 mL/min and UV detector set at 315 nm has shown a good chromatographic separation for Febuxostat and its related substances. The developed method was validated as per ICH Guidelines and shown equivalency with API Vendor method. The developed UPLC method has run time of only 10 minutes making the method productive and may be applied for Quality control Testing.