To develop simple, accurate and precise reversed phase high performance liquid chromatography method for the estimation of ketorolac and fluorometholone in the combined ophthalmic dosage form available in the market for conjunctivitis and refractive eye Surgery. Both drugs ketorolac and fluorometholone are present in ratio of 5:1. The separation was made in a hyperchrome ODS-BP (250×4.6 mm, 5 µm C18) using a methanol: water (pH 4.0) (70:30, v/v) as mobile phase at 240 nm. The mobile-phase flow rate and the sample volume injected were 1.0 ml/min and 20 μl, respectively. Retention time of ketorolac and fluorometholone was found to be 5.17 and 3.66 minutes. The correlation coefficient of both drugs was found to be 0.999. Percent recoveries obtained for both the drugs were 99.73-99.89% and 100.430-100.581%. The method was validated according to the ICH guidelines with respect to specificity, linearity, accuracy, precision and robustness. Over all % RSD was found to be less than 2%. The developed method can be used for routine analysis of ketorolac and fluorometholone in their pharmaceutical dosage forms.
Loading....