Article Subject

A reliable and sensitive isocratic stability indicating RP-HPLC method has been developed and validated for assay of Febuxostat in tablets and for determination of content uniformity. An isocratic separation of Febuxostat was achieved on Zodiac C18 column (250 X 4.6 mm, 5μ) particle size columns with a flow rate of 1.1 ml/min and using a UV detector to monitor the eluate at 218nm. The mobile phase consisted of Acetonitrile : Methanol (85:15 v/v).The drug was subjected to oxidation, hydrolysis, photolysis and thermal degradation. All degradation products in an overall analytical run time of approximately 10min with the parent compound Febuxostat eluting at approximately 4.87min. Response was a linear function of drug concentration in the range of 40-100μg/ml (r 2 = 0.9991). Accuracy (recovery) was between 98.00- 100.86. Degradation products resulting from the stress studies did not interfere with the detection of Febuxostat and the assay is thus stability-indicating.

method validation
stability- indicating
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