Development and Validation of RP-HPLC Method for the Simultaneous Estimation of Ketorolac Tromethamine and Olopatadine Hydrochloride in Pure and Pharmaceutical Formulation

A simple, fast, precise, selective and accurate RP-HPLC method was developed and validated for the simultaneous determination of Ketorolac tromethamine and olopatadine HCl from bulk and formulations. Chromatographic separation was achieved isocratically on a Inertsil ODS C18 column (250×4.6 mm, 5 μ particle size) using a mobile phase 0.1 M Sodium di hydrogen orthophosphate: Acetonitrile in the ratio of 55:45. The flow rate was 1 ml/min and effluent was detected at 235nm. The retention time of Ketorolac and olopatadine were 2.507 min and 4.933 min. respectively. Linearity was observed in the concentration range of 4-24μg/ml and 12-72μg/ml for Ketorolac and olopatadine respectively with correlation coefficient of 0.999 for both the drugs. Percent recoveries obtained for ketorolac and olopatadine were 100.03% and 100.04%, 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 Ketorolac and olopatadine from their combined dosage form.