title: Liquid chromatography-tandem mass spectrometry quantification of levosulpiride in human plasma and its application to bioequivalence study.
abstract: An improved method for determining levels of levosulpiride in human plasma using ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) was developed and validated. The protein precipitation method was used for plasma sample preparation. Levosulpiride and an internal standard (IS) were isocratically separated on a UPLC BEH C(18) column with a mobile phase of ammonium formate buffer (1mM, adjusted to pH 3 with formic acid) and acetonitrile (60:40, v/v). MS/MS detection was performed by monitoring the parent-->daughter pair of levosulpiride and the IS at m/z 342-->112 and 329-->256, respectively. The method was linear from 2.5 to 200ng/mL and exhibited acceptable precision and percent recovery. The method was successfully demonstrated in pharmacokinetic and bioequivalence studies of two levosulpiride oral formulations administered to healthy volunteers. When compared to the previous LC-MS methods, the proposed method is faster, well-validated, and uses lesser plasma volume and a similar sensitivity. The use of UPLC allowed rapid and sensitive quantification of levosulpiride, making this method suitable for high-throughput clinical applications.
authors.affiliation: Department of Molecular Medicine, Kyungpook National University School of Medicine, Daegu, South Korea.
authors.forename: Prasad B
authors.initials: PB
authors.lastname: Phapale
authors.forename: Hae Won
authors.initials: HW
authors.lastname: Lee
authors.forename: Mi-Sun
authors.initials: MS
authors.lastname: Lim
authors.forename: Sook Jin
authors.initials: SJ
authors.lastname: Seong
authors.forename: Eun-Hee
authors.initials: EH
authors.lastname: Kim
authors.forename: Jeonghyeon
authors.initials: J
authors.lastname: Park
authors.forename: Miran
authors.initials: M
authors.lastname: Lee
authors.forename: Sung-Kyu
authors.initials: SK
authors.lastname: Hwang
authors.forename: Young-Ran
authors.initials: YR
authors.lastname: Yoon
mesh_terms: D000328:Adult; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D006801:Humans; D008297:Male; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013469:Sulpiride / Q000031:analogs & derivatives* / Q000097:blood / Q000493:pharmacokinetics; D053719:Tandem Mass Spectrometry / Q000379:methods*; D013810:Therapeutic Equivalency; D013976:Tiapamil Hydrochloride / Q000032:analysis
chemical_list: D013469:Sulpiride; C078143:levosulpiride; D013976:Tiapamil Hydrochloride