A Validated RP-HPLC Method for the Estimation of Febuxostat in Bulk Drugs

Authors: Sudhir S Muvvala1, Venkata Nadh Ratnakaram, Rama RaoNadendla3

An accurate, sensitive, precise and robust reverse phase high performance liquid chromatographic (RP-HPLC) method for the estimation of Febuxostat in bulk forms has been developed and validated. Chromatographic separation is conducted on Nucleosil C18 (250 x 4.6mm, 5μm) column at ambient temperature using mixture of 10 mM ammonium acetate buffer (buffer of pH 4.0 adjusted with 0.2% triethyl amine) and acetonitrile in the ratio (15: 85, v/v) as a mobile phase and at a flow rate of 1.2 ml / min, while UV detection is performed at 275nm. The retention time for Febuxostat is found to be 3.45 ± 0.05 min. The method is found to be linear in the range of 50.0 – 400.0 μg/mL. The limit of detection and quantization for Febuxostat are found to be 9.98 and 30.23 μg /mL respectively. Analytical recovery is 99.29 %. The percentage RSD for precision and accuracy of the method is found to be less than 2%. The method is validated as per the ICH guidelines and applied for the quantitative analysis of Febuxostat in bulk forms.

Comments: 9 Pages. OK

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[v1] 2019-05-19 06:00:10

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