title: Determination of bifendate in human plasma by HPLC-MS and bioequivalence on bifendate pills in healthy volunteers.
abstract: A sensitive and specific method for the determination of bifendate in human plasma was developed, based on high-performance liquid chromatography (HPLC)-mass spectrometry (MS). The samples were extracted from plasma with diethyl ether, followed by separation and evaporation after addition of internal standard diazepam. The residue was reconstituted in methanol and injected into the HPLC-MS. Chromatography was performed on an Inertsil ODS column with a mobile phase consisting of methanol-distilled water (70/30, v/v) at a flow rate of 0.3 mL/min. Quantitative analysis was achieved by MS detection, using a mass spectrometer equipped with an electrospray ionization interface (ESI) and operated in selected ion monitoring (SIM) and positive-ionization mode using target ions at m/z 419 for bifendate and m/z 285 for internal standard, respectively. The linearity was confirmed in the concentration range of 2-200 ng/mL in human plasma and the precision of this assay was not more than 6.79% over the entire concentration range. The method was sensitive and repeatable enough to be used in pharmacokinetic and bioavailability studies.
authors.affiliation: Department of Pharmaceutical Analysis, School of Pharmacy, Fudan University, Box 70, 138 Yi Xue Yuan Road, Shanghai 200032, PR China.
authors.forename: Lingjie
authors.initials: L
authors.lastname: Zhou
authors.forename: Lihua
authors.initials: L
authors.lastname: Gu
authors.forename: Yijian
authors.initials: Y
authors.lastname: Wang
authors.forename: Jianying
authors.initials: J
authors.lastname: Liang
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000097:blood* / Q000493:pharmacokinetics; D001713:Biphenyl Compounds / Q000097:blood* / Q000493:pharmacokinetics; D002851:Chromatography, High Pressure Liquid / Q000379:methods; D006801:Humans; D008297:Male; D015203:Reproducibility of Results; D021241:Spectrometry, Mass, Electrospray Ionization; D013607:Tablets; D013810:Therapeutic Equivalency
chemical_list: D000998:Antiviral Agents; D001713:Biphenyl Compounds; D013607:Tablets; C465548:bifendate