A specific, accurate, precise and reproducible RP-HPLC method has been developed and subsequently validated for the simultaneous determination of ketorolac tromethamine and fluorometholone in ophthalmic formulation. The proposed HPLC method utilizes hypersil (thermo scientific) C18 column (250 mm × 4.6 mm id, 5 μm particle size) and mobile phase consisting of phosphate buffer: methanol (70:30) and pH adjusted to 3.0 with orthophosphoric acid at a flow rate of 1.0 ml/min. Quantitation was achieved with UV detection at 260 nm based on peak area with linear calibration curves at concentration ranges 2.5-7.5 μg/ml for fluorometholone and 12.5-37.5 μg/ml for ketorolac tromethamine. The retention time of fluorometholone and ketorolac tromethamine were found to be 3.69 min and 6.303 min respectively. The method was validated in terms of accuracy, precision, linearity, limits of detection, limits of quantitation and robustness. This method has been successively applied to ophthalmic formulation and no interference from the formulation excipients was found.
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