European Journal of Molecular & Clinical Medicine

Abstract

The 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.