Analytical Method Development and Validation of RP-HPLC Method for the Quantitative Determination of Ketorolac Tromethamine in Bulk & Pharmaceutical Formulations (Research Article)

Author(s): Pratiksha Dilip Kale and Charushila Bhangale

Abstract: A simple, precise, accurate, sensitive, and robust reversed-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the quantitative determination of Ketorolac Tromethamine in bulk drug and pharmaceutical dosage forms. The chromatographic separation was achieved using a C18 column (250 mm × 4.6 mm, 5 μm) with a mobile phase consisting of 0.01 M Ammonium Dihydrogen Orthophosphate Buffer and Acetonitrile (60:40 v/v). The mobile phase was pumped at a flow rate of 1.0 mL/min, and detection was carried out at 313 nm. Under the optimized chromatographic conditions, Ketorolac Tromethamine exhibited a retention time of approximately 7.6 min. The developed method was validated according to ICH guidelines for specificity, precision, intermediate precision, accuracy, linearity, solution stability, robustness, limit of detection (LOD), and limit of quantification (LOQ). The method showed excellent specificity with no interference from blank or excipients at the retention time of Ketorolac Tromethamine. Precision studies demonstrated satisfactory repeatability with %RSD values less than 2.0%. The accuracy of the method was confirmed by recovery studies at 80%, 100%, and 120% concentration levels, yielding mean recoveries of approximately 100.39%. Linearity was established over the concentration range of 16–24 ppm, with a correlation coefficient (R²) of 0.9978, indicating excellent linear relationship between concentration and peak area. The LOD and LOQ values were found to be 0.6 ppm and 1.7 ppm, respectively, demonstrating adequate sensitivity of the method. Robustness studies showed that small deliberate variations in chromatographic conditions did not significantly affect the assay results. Solution stability studies confirmed that the sample solutions remained stable for up to 24 hours under room temperature conditions. The validated RP-HPLC method was found to be simple, reliable, reproducible, and suitable for routine quality control analysis and assay determination of Ketorolac Tromethamine in bulk drug substances and pharmaceutical formulations.

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