HPLC-MS/MS method for determination of bezafibrate concentration in human plasma and its pharmacokinetics in healthy volunteers
10.13699/j.cnki.1001-6821.2016.13.011
- VernacularTitle:HPLC－MS／MS法测定血浆中苯扎贝特浓度及其药代动力学研究
- Author:
Ya-Lu ZHANG
1
;
Xin-Yue JIAO
;
Heng ZHENG
;
Yi-Ceng LOU
Author Information
1. 武汉理工大学 化学化工与生命科学学院
- Keywords:
bezafibrate;
HPLC-MS/MS;
pharmacokinetic
- From:
The Chinese Journal of Clinical Pharmacology
2016;32(13):1188-1191
- CountryChina
- Language:Chinese
-
Abstract:
Objective To establish a HPLC-MS/MS method for deter-mination of human plasma concentrations of Bezafibrate , and for the study of pharmacokinetic characteristics of bezafibrate ( two formulations ) . Methods Chromatographic separation was using Welch Ultimate C 18 column (5 μm, 2.1 mm ×50 mm) with gradient elution ( A: acetoni-trile, B:water with 0.02% formic acid).Quantification was performed using Q-TRAP MS with multiple-reaction monitoring .Six health sub-jects were divided into three groups and received single 400 mg dose of test preparation or reference preparation in three period .Plasma samples were collected at different time.The concentrations of bezafibrate were determined by LC -MS/MS. Pharmacokinetic parameters and related statistics analysis were calculated by DAS 3.2.7.Results The linear range is 50.0-1.5 ×10 4 ng? mL-1 , and had a good linear relationship ( r=0.996 9 ).The lower limit of quantitation of bezafibrate was 50 ng? mL-1 .The intra-and inter-day precisions were 1.21%-6.36%and 5.73%-7.62%, respectively.And the absolute recoveries of beza-fibrate were range from 67.56%to 77.42%.The main pharmacokinetic parameters of single oral test preparation were:Cmax was (14.52 ±4.78 )μg? mL-1 , tmax was ( 3.00 ±0.89 ) h, t1/2 was ( 2.49 ±0.84 ) h, AUC0-t was ( 52.36 ±6.23 )μg? mL-1? h, AUC0-∞ was (52.48 ±6.19 )μg? mL-1? h.According to the coefficient of variation to estimate sample size was 18 cases.Conclusion This study established a rapid , efficient and sensitive method for the analysis of the concentration of bezafibrate in plasma and also suitable for pharmacokinetic studies of bezafibrate .
