A new liquid chromatographic method for the simultaneous determination of ketorolac tromethamine and fluorometholone in the presence of hydrochlorothiazide

Abstract

Introduction: Ketorolac is used to treat eye pain and to relieve the itchiness and burning of seasonal allergies. Fluorometholone is a synthetic glucocorticoid used for treating eye inflammatory diseases. A simultaneous and new RP-HPLC method was developed for the estimation of Ketorolac tromethamine and Fluorometholone in ophthalmic solutions using Hydrochlorothiazide as an internal standard. Materials and Methods: Shimadzu Model CBM-20A/20 Alite with phenomenex C8 column (250 mm × 4.6 mm i.d., 5 μm particle size) was used for the chromatographic study. 0.1 % acetic acid and methanol (20: 80, v/v) mixture was used as mobile phase with flow rate 0.7 ml/min and UV detection at 241 nm. Results and Discussion: Linearity was observed over the concentration range 1-100 μg/ml with regression equation y = 0.1047x + 0.0006 and correlation coefficient 0.9993 and the method was validated as per ICH guidelines. Conclusions: The method is more precise and accurate and suitable for the quality control analysis of combined formulations of Fluorometholone and Ketorolac tromethamine.