Abstract

ANALYSIS OF KETOROLAC IN HUMAN URINE AND SIMULATED HUMAN URINE BY UHPLC-DAD: METHOD DEVELOPMENT AND VALIDATION

Gamal M. Mahrous*

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Abstract

Ketorolac is a member of the pyrrolo-pyrrole group of non-steroidal anti-inflammatory drug. It is a potent antipyretic and antiinflammatory. It is mainly used for the short term treatment of postoperative mild to moderately severe pain by inhibiting the bodily synthesis of prostaglandins. In the present study, new UHPLC-DAD method for the analysis of KTR in standard form, spiked simulated urine and spiked human urine samples was developed and validated in the present investigation. The method utilized C18 as stationary phase and a combination of acetonitrile: water pH 4(3:7) as an eluent. It was found that selected eluent provided short run time (2.4 min.), and better peak symmetry. Excellent linear relationship (r2 0.9996) was observed for linear regression data for the calibration plots. The developed system was validated according to ICH guidelines. Analysis of KTR in spiked simulated urine and spiked human urine samples gave recovery of 99.47 % and 101.51% of drug respectively. Results obtained from the statistical treatment of the values obtained for different parameters proved that the method is suitable, reproducible and selective for the analysis of KTR in bulk, spiked simulated urine and spiked human urine samples.

Keywords: Ketorolac, UHPLC-DAD, Chromatography, Simulated Urine, Urine.