title: Normal-phase liquid chromatography coupled with electrospray ionization mass spectrometry for chiral separation and quantification of clevudine and its enantiomer in human plasma.
abstract: A new, simple and enantioselective normal-phase liquid chromatography-mass spectrometry method was presented for the quantification of clevudine and its enantiomer in human plasma. A C18 cartridge was used in this method to extract the enantiomers in 200μL plasma followed by a chiral separation on a cellulose-based LC column with mobile phase consisted of hexane, methanol and ethanol (62:28:10, V/V/V). The eluate was directed to a mass spectrometry through an electrospray ionization interface. A transition of m/z 261.0 to m/z 126.8 was used for monitoring of clevudine and its enantiomer. This method showed good linearity (R>0.997), precision (<9.6%) and accuracy (within 95.48-105.9%) within a range of 10-1000ng/mL for the enantiomers and has been applied to the pharmacokinetics study of clevudine capsules in human plasma.
authors.affiliation: Shanghai Institute of Pharmaceutical Industry, National Pharmaceutical Engineering and Research Center, 1111 Halei Road, Zhangjiang Hi-Tech Park, Shanghai 201203, PR China.
authors.forename: Cungang
authors.initials: C
authors.lastname: Ding
authors.forename: Qinghua
authors.initials: Q
authors.lastname: Ge
authors.forename: Yemu
authors.initials: Y
authors.lastname: Wang
authors.forename: Zhen
authors.initials: Z
authors.lastname: Zhou
authors.forename: Xiaojin
authors.initials: X
authors.lastname: Zhi
authors.forename: Xiaofen
authors.initials: X
authors.lastname: Liu
authors.forename: Zhou
authors.initials: Z
authors.lastname: Li
mesh_terms: D001086:Arabinofuranosyluracil / Q000031:analogs & derivatives* / Q000097:blood / Q000737:chemistry / Q000493:pharmacokinetics; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D004355:Drug Stability; D006801:Humans; D016018:Least-Squares Analysis; D057230:Limit of Detection; D021241:Spectrometry, Mass, Electrospray Ionization / Q000379:methods*; D013237:Stereoisomerism
chemical_list: D001086:Arabinofuranosyluracil; C034935:clevudine