A validated RP-HPLC method for simultaneous estimation of moxifloxacin hydrochloride and ketorolac tromethamine in ophthalmic dosage form

A simple, specific and fast reverse phase liquid chromatographic method is established for determination of moxifloxacin hydrochloride and ketorolac tromethamine in bulk drugs and pharmaceutical formulations. Chromatographic separations for separation of moxifloxacin hydrochloride and ketorolac tromethamine were achieved within 8 minutes by use of Inertsil ODS-3V C8 column (250 X 4.6 mm, 5 μm) as stationary phase with mobile phase containing 10 mM potassium dihydrogen phosphate buffer with triethylamine (pH 3.5±0.05 adjusted with dilute phosphoric acid) acetonitrile and methanol (40:30:30 v/v/v) at a flow rate of 1.0 ml/ min-. Detection was performed at 306 nm using Prominance UV-Visible detector. The method was validated in accordance with ICH guidelines. Response was a linear function of concentrations over the range of 60-140 μg/ ml for moxifloxacin hydrochloride and 48-112 μg/ ml for ketorolac tromethamine. Limit of quantification (LOQ) was found to be 5.89, 5.29 and limit of detection (LOD) 1.94, 1.75 μg /ml for moxifloxacin hydrochloride and ketorolac tromethamine respectively. Accuracy and precision values of both within run and between-run obtained from six different sets of three quality control (QC) samples analyzed in separate occasions for both the analytes ranged from 98.98% to 100.04% respectively. The developed and validated method was successfully applied to quantitative determination of moxifloxacin hydrochloride and ketorolac tromethamine in pharmaceutical formulation.