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HPCE AND HPLC METHODS FOR DETERMINATION OF CLOPIDOGREL AND ITS CARBOXYLIC ACID METABOLITE IN BIOLOGICAL SAMPLES: A COMPARATIVE ANALYSIS

A comparison between two analytical techniques (HPCE and HPLC) with UV detection for the determination of clopidogrel (CLP) and its carboxylic acid metabolite (CLPM) in biological fluids was performed. Resolution of the analytes by HPLC method was obtained on a C18 column with the use of a mobile phase consisted of acetonitrile and 0.03 M phosphate buffer at pH 3.0. HPCE analysis was performed in an uncoated capillary filled with an 0.025 M phosphate buffer at pH 2.5. A comparison of the both methods was performed in terms of validation parameters. Statistical analysis, Bland-Altman method, and ATE/LER zone method were also applied for assessing agreement between two methods. It was concluded that the HPLC method produced comparable results to the HPCE method with respect to the analysis of CLPM in plasma samples. Moreover, HPCE offered several advantages such as a lower solvent consumption and a higher selectivity of the analytes in plasma and urine samples. On the other hand, HPLC displayed excellent retention time repeatability in comparison to HPCE method. This study highlights the effective possibilities of application of both methods in the analysis of CLPM in plasma samples obtained from patients undergoing CLP therapy prior to percutaneous coronary intervention.