Development and validation of Ketorolac Tromethamine in eye drop formulation by RP-HPLC method

Abstract

A simple, precise and accurate method was developed and validated for analysis of Ketorolac Tromethamine in eye drop formulation. An isocratic HPLC analysis was performed on Kromosil C18 column (150 cm × 4.6 mm × 5 μm). The compound was separated with the mixture of methanol and ammonium dihydrogen phosphate buffer in the ratio of 55:45 V/V, pH 3.0 was adjusted with O-phosphoric acid as the mobile phase at flow of 1.5 mL min−1. UV detection was performed at 314 nm using photo diode array detection. The retention time was found to be 6.01 min. The system suitability parameters such as theoretical plate count, tailing and percentage RSD between six 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.

Keywords

• Ketorolac Tromethamine
• RP-HPLC method
• PDA detector