HPLC Method for the Determination of Bezaf ibrate in Human Plasma and Application to a Pharmacokinetic Study of Bezaf ibrate Dispersible Tablet

摘要

A sensitive and selective high-performance liquid chromatographic-UV (HPLC-UV) method for the determination of bezafibrate in human plasma has been developed. Sample treatment was based on protein precipitation with a perchloric acid-methanol solution 10:90 (v/v). Analytical determination was carried out by HPLC with UV detection at 235 nm. Chromatographic separation was achieved on a C18 column by isocratic elution with acetonitrile-ammonium acetate aqueous solution (10 mmol/L; pH 4.0) (44:56, v/v) at a flow rate of 1.0 mL/min. The method was linear in the concentration range of 0.1-15.0 ug/mL. The lower limit of quantitation was 0.1 ug/mL. The intra-and inter-day relative standard deviation across three validation runs over the entire concentration range was less than 6.96%. The accuracy determined at three concentrations (0.2, 2.0, and 10.0 ug/mL for bezafibrate) was within ± 10.0% in terms of accuracy. The method was successfully applied for the evaluation of pharmacokinetic profiles of bezafibrate dispersible tablet in 20 healthy volunteers. The results show that AUC, Cmax, and T-i/2 between the testing formulation and reference formulation have no significant difference (P> 0.05). Relative bioavailability was 105.0 ± 15.7%.