HPLC method for the determination of bezafibrate in human plasma and application to a pharmacokinetic study of bezafibrate dispersible tablet.
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 microg/mL. The lower limit of quantitation was 0.1 microg/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 microg/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, C(max), and T(1/2) between the testing formulation and reference formulation have no significant difference (P > 0.05). Relative bioavailability was 105.0 +/- 15.7%.
Wei
Zhang
Z
Center for Instrumental Analysis, China Pharmaceutical University (Key Laboratory of Drug Quality Control and Pharmacovigilance, Ministry of Education), Nanjing 210009, PR China.
Bing-ren
Xiang
X
Ying
Zhan
Z
Liyan
Yu
Y
Teng
Wang
W
Cai-yun
Wang
W
D001629:Bezafibrate / Q000097:blood* / Q000737:chemistry / Q000493:pharmacokinetics*; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D006801:Humans; D000960:Hypolipidemic Agents / Q000097:blood / Q000493:pharmacokinetics; D015394:Molecular Structure; D015203:Reproducibility of Results; D013056:Spectrophotometry, Ultraviolet; D013607:Tablets
D000960:Hypolipidemic Agents; D013607:Tablets; D001629:Bezafibrate