A NOVEL STABILITY INDICATING RP-HPLC METHOD FOR THE DETERMINATION OF KETOROLAC TROMETHAMINE IN PHARMACEUTICAL FORMULATIONS
Abstract
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Objective: The main objective of the present investigation was to develop a simple isocratic stability indicating reversed phase liquid chromatographic
method and validate the proposed method and to apply it for the estimation of ketorolac tromethamine, a non-steroidal anti-inflammatory drug in
pure and pharmaceutical formulations.
Methods: Waters high performance liquid chromatographic 2695 series system, inertsil ODS, C18 (150 mm × 4.6 mm × 5.0 μ) column and UV-visible
detector with photo diode array detection was adopted for the method development. The components were separated by injecting about 20 μL
working standard solution of concentration 5 μg/mL, using mobile phase prepared by mixing buffer of 100 mM potassium dihydrogen orthophosphate
solution of pH 4.5 and acetonitrile in the ratio 60:40 v/v at a flow rate of 0.8 mL/minute, and the components were detected at a wavelength of 316 nm.
Results: The proposed method was validated as per ICH guidelines. The developed method was found to be precise, accurate, linear, robust and
rugged. A study of forced degradation was carried out and found that the drug was stable under variety of degradation conditions.
Conclusion: The proposed method was adopted for assay of pharmaceutical formulations and recommended for routine analysis in any quality
control laboratory.
Keywords: Ketorolac tromethamine, Validation, Assay, Forced degradation, Pharmaceutical formulations.
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