Asian Journal of Pharmaceutical Analysis

A reliable, rapid and sensitive isocratic reverse phase high-performance liquid chromatography (RP-HPLC) method has been developed and validated for analysis of Ketorolac Tromethamine (KT) for the estimation and comparison of ketorolac tromethamine in proniosomal gel and marketed gel formulation. An isocratic separation was achieved on Shimizu C18 column (250 cm×4.6 mm×5 μm) at ambient temperature by optimizing the experimental conditions. The compound was separated with the mixture of methanol and water in the ratio of 60: 40 V/V, pH 3.0 was adjusted with 0.1% o-phosphoric acid as the mobile phase at flow of 1.5 mL min⁻¹. The eluents were monitored at 306 nm using photo diode array detection. The average retention time of five readings was found to be 6.936 min. The system suitability parameters like theoretical plate count, tailing factor and relative standard deviation of five standard injections were within the limit. The method was validated according to ICH guidelines. Calibrations were linear over the concentration range of 50–150 μg mL⁻¹ as indicated by correlation coefficient (r) of 0.999. The robustness of the method was evaluated by deliberately altering the chromatographic conditions. The developed method can be applicable for routine quantitative analysis.