HPLC determination of bezafibrate in human plasma and its application to pharmacokinetics studies.
An isocratic high-performance liquid chromatographic (HPLC) method was developed and validated for the determination of bezafibrate in biological fluids. Bezafibrate was separated on a C(18) analytical column (150 x 4.6 mm i.d., 5 microm particle size) with 0.01 M phosphate buffer (pH 3.5)-acetonitrile-methanol (50:40:10) as mobile phase at a flow rate of 1.0 mL/min. The UV detector was set to 230 nm. Bezafibrate was extracted from human plasma using a simple liquid-liquid extraction with tert-butyl methyl ether. Parameters such as linearity, precision, accuracy, recovery, specificity, and stability were evaluated by method validation studies. All the parameters remained within acceptable limits. The validated procedure was linear in the concentration range of 0.2-50 microg/mL. The proposed method used for individual drug determinations is applicable for therapeutic monitoring purposes as well as for use in pharmacokinetic investigations. As an example, the practical quantification limit for bezafibrate in plasma was about 0.05 microg/mL with precision of 10.2% and accuracy of 112.6%. The method was applied in a study of the pharmacokinetics of bezafibrate in six healthy volunteers, who ingested a single oral dose of 200 mg.
Programa de Pós-Graduação em Ciências Farmacêuticas, Centro de Ciências da Saúde, Universidade Federal de Santa Maria, 97105-900, Santa Maria, RS, Brazil.
Janine
J
de Melo
Felipe Kellermann
FK
Hurtado
Fabia Silveira
FS
Poitevin
Fernanda Cramer
FC
Flores
Estevan Sonego
ES
Zimmermann
Sergio Luiz
SL
Dalmora
Clarice Madalena Bueno
CM
Rolim
D001629:Bezafibrate / Q000097:blood* / Q000493:pharmacokinetics; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D006801:Humans; D000960:Hypolipidemic Agents / Q000097:blood* / Q000493:pharmacokinetics
D000960:Hypolipidemic Agents; D001629:Bezafibrate