DEVELOPMENT & VALIDATION OF A RP-HPLC METHOD FOR THE DETERMINATION OF KETOROLAC TROMETAMOL AND ITS IMPURITIES IN PHARMACEUTICAL DOSAGE FORM 30 MG/ML SOLUTION FOR INJECTION
European Journal of Molecular & Clinical Medicine,
2022, Volume 9, Issue 7, Pages 4118-4132
AbstractThe analysis of established HPLC technique for the separation and quantification of Ketorolac trometamol and its impurities are described. Samples are analysed by reverse phase (RP-HPLC) using stationary phase Inert sustain (250 x 4.6mm, 5µm) column and the movable segment consisted of water, methanol and glacial acetic acid in the proportion of (49:50:1 %volume/volume/volume). The run velocity is 1.0 mL/min, the column oven was preserved at 40°C and sampler cooler oven was preserved 5°C, infused 10µL and wavelength fixed at 313nm UV-detection. The established HPLC technique was authenticated with admiration to specificity, precision, linearity, accuracy, LOD, LOQ and solution stability. Corroboration study compared as stated by ICH instruction.
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