ISSN: 2249–9504
CAS CODEN: IJPCDX

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF FEBUXOSTAT AND KETOROLAC IN TABLET DOSAGE FORMS BY RP-HPLC

Abstract

Author(s): B. Raja1and A. Lakshmana Rao2*

A simple, accurate, precise and rapid reversed-phase high performance liquid chromatographic (RP-HPLC) method has been developed and validated for the simultaneous estimation of Febuxostat and Ketorolac in pure and tablet dosage form. The proposed method is based on the separation of the two drugs in reversed-phase mode using C18 column (150 mm x 4.6 mm I.D., 5 μ particle size). The optimum mobile phase consisted of phosphate buffer: acetonitrile in the ratio of 50:50 V/V was selectedas a mobile phase, flow rate of 0.7 mL/min and UV detection was set at 299 nm. The retention times were 2.648 min and 5.389 min forFebuxostat and Ketorolac. The method was validated according to ICH guidelines. Linearity wasobtained in the concentration range of 10-60 μg/mL for Febuxostat and 3.75-22.5 μg/mL for Ketorolac. Mean percent recovery of samples for both drugs were found in the range of 100.62 for Febuxostat and 100.67 for Ketorolac. The relative standard deviation(%RSD) was found to be 0.09 for Febuxostat and 0.03 for Ketorolac. The proposed method is rapid, accurate, precise and selective for the simultaneous estimation of Febuxostat and Ketorolac and can be successfully applied in the quality control of bulk andpharmaceutical dosage forms.

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