Romanian Society of Pharmaceutical Sciences
 

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SIMULTANEOUS DETERMINATION OF FIBRATES BY MICELLAR ELECTROKINETIC CAPILLARY CHROMATOGRAPHY

ELEONORA MIRCIA1, GABRIEL HANCU2, OANA NIȚU2, HAJNAL KELEMEN2*, MELANIA CÂRCU-DOBRIN2, ȘERBAN ANDREI GÂZ1, TEODORA BALACI3

1.Department of Organic Chemistry, Faculty of Pharmacy, University of Medicine and Pharmacy, Târgu Mureş, Romania
2.Department of Pharmaceutical Chemistry, Faculty of Pharmacy, University of Medicine and Pharmacy, Târgu Mureş, Romania
3.Department of Pharmaceutical Technology and Biopharmacy, Faculty of Pharmacy, “Carol Davila” University of Medicine and Pharmacy, Bucharest, Romania

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Fibrates are effective hypolipidemic agents used for a large range of metabolic disorders, mainly hypercholesterolemia, with peroxisome proliferator–activated receptor agonist activity. Even though fibrates are not used in combination with other fibrates during therapy, the development of a rapid general analytical procedure that will not be limited to the analysis of only one fibrate could be very useful. Four fibrates - bezafibrate, clofibrate, fenofibrate and gemfibrozil were analysed by capillary electrophoresis. Migration time and selectivity were examined in different separation buffers at different pH values, varying the separation voltage, the system temperature and the injection parameters. While bezafibrate and gemfibrozil are ionizable analytes and can be determined by capillary zone electrophoresis, clofibrate and fenofibrate are neutral from the electrophoretic point of view and can be determined only using micellar electrokinetic capillary chromatography. The four analytes were determined simultaneously with high resolution and fast migration times. The analytical performance of the method was verified regarding precision, linearity, robustness and limits of detection and quantification were calculated. The method was applied for the determination of fenofibrate from pharmaceutical preparations.