Author(s): Mahesh Nasare, S.Harshini*, A.Manikanta Kumar and V. PrakashDiwan
A simple, specific, accurate, precise, selective, economic and rapid reverse phase high performance liquid chromatography (RP-HPLC) method for the estimation of febuxostat in bulk and pharmaceutical dosage forms has been developed and validated. The chromatographic separation for febuxostat was achieved on a reverse phase Phenomenex® (Luna 5μ C18 (2) 100A (250 × 4.60 mm) i.d column in isocratic mode at ambient temperature by using mobile phase consisting of water : acetonitrile (30:70% v/v) delivered at a flow rate of 0.7 mL min-1. The retention time of febuxostat and internal standard (tinidazole) were found to be 2.495 ±0.177 and 3.915 ± 0.005 minutes respectively. The analyte molecule was monitored at 314 nm by UV detector. The developed method gave good resolution between febuxostat and internal standard. Different analytical performance parameters such as linearity, precision, accuracy, specificity, limit of detection, limit of quantification, robustness and ruggedness were determined accordingto ICH guidelines. The calibration curve was linear over the concentration range of 1-7μg mL-1. The mean recoveries obtained for febuxostat were found to be 99.02 to 102 %, so the proposed method is accurate. Limit of detection and limit of quantificationfor febuxostat were 0.01 and 1μg mL-1respectively, therefore the method employed as a more convenient for the analysis of febuxostat and its related compounds in drug substance and formulations and can be used for routine quality control analysis.