A New Isocratic RP-HPLC Assay Method Development and Validation of Febuxostat in Tablet Dosage Form

Febuxostat is a selective inhibitor of xanthine oxidase that is used to treat hyperuricemia in gout patients. For the determination of Febuxostat, an isocratic liquid chromatographic technique RP-HPLC was devised and validated. By using phosphate buffer (pH 3.0): methanol: acetonitrile (40:20:40, v/v) as a Mobile phase and 1.0 mL/min flow rate at room temperature, chromatographic separation was obtained on a (4.6 x 150mm 3.5um Agilent XBD) C18 column. The injection capacity is 20 liters, and the run time is 7 minutes. The wavelength of detection is set to 317nm. The linear correlation coefficient (R2) was found to be 1.000, with a -0.0035 percent y intercept. The detection limit was determined to be 0.0056ppm while the quantification limit was found to be 0.018ppm. Febuxostat was proven to be 99.85% pure. The requirements for repeatability and precision have been met. For the determination of Febuxostat in pharmaceutical dosage forms, the approach is simple, specific, precise, durable, and accurate (tablets).