ESTIMATION OF RELATED SUBSTANCES OF FEBUXOSTAT IN BULK & 40/80/120mg TABLETS BY RP-HPLC
Journal Title: International Journal of Pharmaceutical, Biological and Chemical Sciences (IJPBCS) - Year 2012, Vol 1, Issue 2
Abstract
A simple reverse phase liquid chromatographic method was developed for the determination of related substances in Febuxostat in bulk and Tablets. The related substances amide impurity, methyl ester impurity and ethyl ester impurity with Febuxostat separated on a Poroshell 120 E18C18 column (500 mm x 4.6 mm; 2.7µ) using a mobile phase mixture of phosphate buffer pH 3.0 and methanol in a gradient program at a flow rate of 1.0ml/min at a wavelength of 318 nm. The method was validated for Linearity, speficity, LOD, LOQ, accuracy, robustness, ruggedness, precision, Filter paper variation and solution stability. The retention time of Febuxostat was 3.6±0.1 min. The propose method was validated as per the ICH guidelines. The method was accurate, precise, specific and rapid found to be suitable for the quantitative estimation of the impurities in drug and pharmaceutical dosage form.
Authors and Affiliations
M. NARESH CHANDRA REDDY*1 , K. B. CHANDRA SEKHAR2
Keywords
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- EP ID EP119842
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