title: Quantification of prochlorperazine maleate in human plasma by liquid chromatography-mass spectrometry: Application to a bioequivalence study.
abstract: A sensitive and specific method using a one-step liquid-liquid extraction with dichloromethane followed by liquid chromatographic-electrospray ionization-mass spectrometric was developed and validated to determine prochlorperazine maleate in human plasma using amitriptyline hydrochloride as an internal standard. The samples were separated using a Thermo Hypersil-Hypurity C18 reversed-phase column (150mmx2.1mm i.d., 5mum). A mobile phase containing 10mM ammonium acetate (pH 3.6)-methanol-acetonitrile (27:68:5, v/v/v) was used isocratically eluting at a flow rate of 0.22ml/min. The average extraction recovery of prochlorperazine and internal standard were 81.8+/-2.2% and 79.5+/-3.7%, respectively. Prochlorperazine maleate and internal standard were measured by electrospray ion source in positive selective ion monitoring mode. The method demonstrated that good linearity ranged from 0.20 to 6.40ng/ml with r(2)=0.9989. The limit of quantification for prochlorperazine maleate in the plasma was 0.20ng/ml. The established method has been successfully applied to a bioequivalence study of two prochlorperazine maleate formulations in 18 healthy male Chinese volunteers.
authors.affiliation: Clinical Pharmacy & Pharmacology Research Institute, The Second Xiangya Hospital of Central South University, 139# Middle Renmin Road, Changsha, Hunan 410011, China.
authors.forename: Miao
authors.initials: M
authors.lastname: Yan
authors.forename: Yun-Gui
authors.initials: YG
authors.lastname: Zhu
authors.forename: Huan-De
authors.initials: HD
authors.lastname: Li
authors.forename: Ben-Mei
authors.initials: BM
authors.lastname: Chen
authors.forename: Ning
authors.initials: N
authors.lastname: Ma
authors.forename: Yan-Qing
authors.initials: YQ
authors.lastname: Lei
authors.forename: Yi-Ping
authors.initials: YP
authors.lastname: Liu
mesh_terms: D002853:Chromatography, Liquid / Q000379:methods*; D004355:Drug Stability; D006801:Humans; D016014:Linear Models; D008297:Male; D011346:Prochlorperazine / Q000097:blood* / Q000493:pharmacokinetics; D012680:Sensitivity and Specificity; D021241:Spectrometry, Mass, Electrospray Ionization / Q000379:methods*; D013810:Therapeutic Equivalency
chemical_list: D011346:Prochlorperazine