Quantitative determination of pimozide in human plasma by liquid chromatography-mass spectrometry and its application in a bioequivalence study.
A simple, sensitive and specific LC-ESI/MS method was developed for the determination of pimozide in human plasma. Pimozide and cinnarizine (internal standard) were isolated from plasma samples by liquid-liquid extraction. The chromatographic separation was accomplished on a Thermo Hypersil-HyPURITY C18 reversed-phase column (150mmx2.1mm, i.d., 5microm) with the mobile phase consisting of 5mM ammonium acetate (pH 3.5, adjusted with acetic acid)-methanol-acetonitrile (39:5:56, v/v/v). The lower limit of quantification was 0.02ng/mL, and the assay exhibited a linear range of 0.025-12.800ng/mL. The established method has been successfully applied to a bioequivalence study of 2 pimozide formulations in 32 healthy male Chinese volunteers.
Yan
Miao
M
Clinical Pharmacy & Pharmacology Research Institute, The Second Xiangya Hospital of Central South University, 139# Middle Renmin Road, Changsha, Hunan Province 410011, PR China.
Li
Huan-De
HD
Chen
Ben-Mei
BM
Liu
Xiao-Lei
XL
Xu
Ping
P
Zhu
Yun-Gui
YG
D000284:Administration, Oral; D014150:Antipsychotic Agents / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D044466:Asian People; D002021:Buffers; D002626:Chemistry, Pharmaceutical; D002853:Chromatography, Liquid / Q000592:standards; D002936:Cinnarizine / Q000097:blood; D018592:Cross-Over Studies; D006801:Humans; D008297:Male; D013058:Mass Spectrometry / Q000592:standards; D010868:Pimozide / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D012015:Reference Standards; D015203:Reproducibility of Results; D013607:Tablets; D013810:Therapeutic Equivalency
D014150:Antipsychotic Agents; D002021:Buffers; D013607:Tablets; D010868:Pimozide; D002936:Cinnarizine