A VALIDATED RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF FEBUXOSTAT AND KETOROLAC TROMETHAMINE IN PHARMACEUTICAL FORMULATIONS

Abstract

A simple, fast, precise, selective and accurate RP-HPLC method was developed and validated for the simultaneous determination of Febuxostat and Ketorolac from bulk and formulations. Chromatographic separation was achieved isocratically on a Waters C18 column (250×4.6 mm, 5 µ particle size) using a mobile phase, Methanol and Ammonium acetate buffer (adjusted to pH 6.0 with 1% orthophosphoric acid) in the ratio of 60:40. The flow rate was 1 ml/min and effluent was detected at 321nm. The retention time of Febuxostat and Ketorolac were 2.62 min and 3.96 min. respectively. Linearity was observed in the concentration range of 5-30µg/ml and 10-60 µg/ml for Febuxostat and Ketorolac respectively with correlation coefficient 0.999 for both the drugs. Percent recoveries obtained for both the drugs were 99.94-99.22% and 99.44-101.06%, respectively. The method was validated according to the ICH guidelines with respect to specificity, linearity, accuracy, precision and robustness. The method developed can be used for the routine analysis of Febuxostat and Ketorolac from their combined dosage form.