"Revolutionizing Ophthalmic Drug Analysis: Simultaneous Quantification of Ofloxacin and Ketorolac Tromethamine using Reverse Phase High Performance Liquid Chromatography"

Abstract

A novel reverse phase high performance liquid chromatographic (HPLC) method was developed to simultaneously quantify Ofloxacin and Ketorolac Tromethamine in both bulk and ophthalmic dosage forms, providing a simple, accurate, rapid, and precise analytical approach. Employing a Eurosphere-100 C18 column (250 mm × 4.6 mm, 5 μm particle size) in isocratic mode with a mobile phase consisting of methanol and 0.005 M potassium dihydrogen phosphate buffer (50:50 v/v), adjusted to pH 3.5 ± 0.1 with ortho-phosphoric acid, facilitated efficient separation. The flow rate was maintained at 1.0 mL/min, and individual component absorbance was measured at 298 nm. Ketorolac Tromethamine and Ofloxacin exhibited retention times of 5.20, and 10.20 minutes, respectively.

The method demonstrated excellent linearity over the concentration ranges of 3-15 μg/mL for Ofloxacin and 5-15 μg/mL for Ketorolac Tromethamine, with correlation coefficient values of 0.9998 for both analytes. Percentage recovery for Ofloxacin and Ketorolac Tromethamine was determined to be 100.28% and 99.70%, respectively, indicative of the method's accuracy and reliability. This innovative HPLC technique offers a robust solution for the simultaneous analysis of these important pharmaceutical compounds, facilitating quality control and ensuring the efficacy of ophthalmic formulations