title: High-performance liquid chromatographic method for determination of clinofibrate and its application to a pharmacokinetic study in healthy volunteers.
abstract: A convenient and rapid HPLC method was developed for the determination of clinofibrate in human plasma using simple protein precipitation with the mixture of acetonitrile and 1M hydrochloric acid (95:5, v/v) followed by separation using an Inspire C(18) column with isocratic elution. The detection wavelength was 232nm and the flow rate was 1.0ml/min. The mobile phase consisted of acetonitrile and water containing 0.4% ortho-phosphoric acid (73:27, v/v). Linear calibration curve was obtained over the concentrations ranging from 0.5μg/ml to 32μg/ml (r(2)=0.999) with LLOQ of 0.5μg/ml. The RSD in both the intra-run and inter-run precision study was less than 5.4% and the extraction recoveries were above 90.7%. The HPLC method is reproducible and suitable for the quantification of clinofibrate in plasma. This method was successfully applied to the pharmacokinetic studies of clinofibrate in healthy volunteers. The elimination half-lives (t(1/2)) were (20.47±3.44), (18.19±2.62) and (21.51±4.78)h after single oral administration of 200, 400 and 600mg clinofibrate, respectively. The results of WinNonlin software showed that the area under the plasma concentration versus time curve from time 0 to 72h (AUC(0-72)) and peak plasma concentration (C(max)) were linearly related to dose (P>0.05).
authors: Department of Pharmacy, First Affiliated Hospital of the Fourth Military Medical University, Changle West Street 15, Xi'an, Shaanxi 710032, China. majam@gumed.edu.pl
authors: Li
authors: L
authors: Jian-Kang
authors: Song
authors: S
authors: Ying
authors: Wang
authors: W
authors: Lei
authors: Chen
authors: C
authors: Minchun
authors: Song
authors: S
authors: Wei
authors: Li
authors: L
authors: Xueqing
authors: Sun
authors: S
authors: Xiao-Li
authors: Li
authors: L
authors: Guangqing
authors: Jia
authors: J
authors: Yan-Yan
authors: Wen
authors: W
authors: Ai-Dong
mesh_terms: D000284:Administration, Oral; D000328:Adult; D019540:Area Under Curve; D002138:Calibration; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D004305:Dose-Response Relationship, Drug; D005260:Female; D006207:Half-Life; D006801:Humans; D000960:Hypolipidemic Agents / Q000493:pharmacokinetics*; D008297:Male; D010642:Phenoxyacetates / Q000493:pharmacokinetics*; D015203:Reproducibility of Results; D012984:Software; D013997:Time Factors
chemical_list: D000960:Hypolipidemic Agents; D010642:Phenoxyacetates; C006231:clinofibrate