Development and validation of RP-HPLC method for determination of ketorolac tromethamine from bulk and pharmaceutical formulations
Abstract
A simple, rapid, specific, precise and accurate Reverse phase high performance liquid chromatographic (RP-HPLC) method was developed for quantitative analysis of Ketorolac tromethamine in bulk and marketed formulations such as tablet, ophthalmic solution and gel and validated as per ICH guidelines. Chromatographic separation was performed on a C18 column using an optimized mobile phase of Methanol: Water (75:25) at a flow rate of 1ml/min using the HPLC method. The detection was done at 319 nm and Ketorolac tromethamine had a retention time 2.522 minutes. The total run time of analysis was 10minutes. The drug obeyed Beers law in the concentration range of 4-12µg/ml and the calibration plot revealed a linear relationship. The LOD and LOQ for ketorolac tromethamine were determined to be 0.415 µg/ml and 1.3 µg/ml, respectively. The accuracy and repeatability studies of the proposed method was found to be in acceptable limits, %RSD was less than 2. The proposed method showed excellent linearity, specificity, accuracy, precision, LOD, LOQ and system suitability results within the acceptance criteria.
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