Stability-Indicating RP-HPLC Method Development and Validation for the Quantification of Ketorolac Tromethamine-Related Impurities in Tablets Solid Oral Dosage Forms

Abstract

The present manuscript discusses the development and validation of a gradient reversed-phase HPLC method for determining impurities in Ketorolac Tromethamine tablet dosage formulations. The analytes were separated using an Agilent Zorbax SB C8 column (250 × 4.6 mm, 5.0-μm particle size). The mobile phase consisted of 0.05-M ammonium phosphate buffer at pH 3.0 (mobile phase A) and a mixture of 40% methanol and 60% tetrahydrofuran (mobile phase B). The column temperature was maintained at 40°C, with a flow rate of 1.0 mL/min. UV detection was performed at 254 nm. The method demonstrated high specificity, with a linearity range of 0.201–6.445 μg/mL and achieving a correlation coefficient of > 0.999. The method exhibited high accuracy, exceeding 97%. The developed method was validated according to international ICH guidelines for specificity, linearity, precision, accuracy, and robustness. Stress studies indicated that Ketorolac Tromethamine tablets were sensitive to basic, photolytic, and oxidative stress conditions. The method was deemed suitable for quality control purposes, including impurity determination in Ketorolac Tromethamine tablets and stability-indicating studies.