Spectrofluorimetric Method for Determination of Febuxostat in Bulk and in Dosage Form ‎

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Febuxostat is a xanthine oxidase inhibitor approved by the US FDA for the management of hyperuricemia in gout patients. The presence of extended unsaturation in planar orientation makes the drug molecule amenable to fluorimetric estimation. The present report describes the validation of simple, rapid, sensitive and cost-effective spectrofluorometric methods based on the native fluorescence of the drug febuxostat in basic medium. Fluorescence characteristics of the drug were found to significantly differ in ethanol (λexcitation 245 nm and λemission 385 nm) and alkaline borate buffer (pH 10.4) (λexc 371 nm and λem 635 nm) and both methods were validated as per the ICH guidelines. The two methods were extremely sensitive, precise and accurate demonstrating excellent linearity in concentration ranges of 0.1-10 μg/ml. The LOD and LOQ values were found to be 0.1255 µg/ml & 0.3803 µg/ml (ethanol) and 0.2183 µg/ml & 0.6616 µg/ml (borate buffer). The proposed methods were used to quantify the drug in its marketed tablet formulation with good recoveries suggesting their applicability to routine analysis of the drug in bulk as well as in formulations.