title: Rapid quantification of levosulpiride in human plasma using RP-HPLC-MS/MS for pharmacokinetic and bioequivalence study.
abstract: A rapid and validated method for analysis of levosulpiride in human plasma using liquid chromatography coupled to tandem mass spectrometry was developed. Levosulpiride and tiapride (IS, internal standard) were extracted from alkalized plasma samples with ethylacetate and separation by RP-HPLC. Detection was performed by positive ion electrospray ionization in multiple-reaction monitoring mode, monitoring the transitions m/z 342.1 --> m/z 112.2 and m/z 329.1 --> m/z 213.2, for quantification of levosulpiride and IS, respectively. The standard calibration curves showed good linearity within the range of 2-200 ng/mL (r(2) > or = 0.9990). The lower limit of quantitation was 2 ng/mL. The retention times of levosulpiride (0.63 min) and IS (0.66 min) presented a significant time saving benefit of the proposed method. No significant metabolic compounds were found to interfere with the analysis. This method offered good precision and accuracy and was successfully applied for the pharmacokinetic and bioequivalence study of a 25 mg of levosulpiride tablet in 24 healthy Korean volunteers.
authors.affiliation: Department of Pharmacology and Institute of Biomedical Sciences, College of Medicine, Hanyang University, Seoul, South Korea.
authors.forename: Jin-Hee
authors.initials: JH
authors.lastname: Park
authors.forename: Yoo-Sin
authors.initials: YS
authors.lastname: Park
authors.forename: Si-Youn
authors.initials: SY
authors.lastname: Rhim
authors.forename: Hyun-Jin
authors.initials: HJ
authors.lastname: Kim
authors.forename: Ok-Hwa
authors.initials: OH
authors.lastname: Jhee
authors.forename: Yun-Sik
authors.initials: YS
authors.lastname: Lee
authors.forename: Min-Ho
authors.initials: MH
authors.lastname: Lee
authors.forename: Leslie M
authors.initials: LM
authors.lastname: Shaw
authors.forename: Ju-Seop
authors.initials: JS
authors.lastname: Kang
mesh_terms: D002138:Calibration; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D018492:Dopamine Antagonists / Q000097:blood* / Q000493:pharmacokinetics; D006801:Humans; D057230:Limit of Detection; D012015:Reference Standards; D013469:Sulpiride / Q000031:analogs & derivatives* / Q000097:blood / Q000493:pharmacokinetics; D053719:Tandem Mass Spectrometry / Q000379:methods*; D013810:Therapeutic Equivalency
chemical_list: D018492:Dopamine Antagonists; D013469:Sulpiride; C078143:levosulpiride