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Rapid quantification of levosulpiride in human plasma using RP‐HPLC‐MS/MS for pharmacokinetic and bioequivalence study
Author(s) -
Park JinHee,
Park YooSin,
Rhim SiYoun,
Kim HyunJin,
Jhee OkHwa,
Lee YunSik,
Lee MinHo,
Shaw Leslie M.,
Kang JuSeop
Publication year - 2009
Publication title -
biomedical chromatography
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.4
H-Index - 65
eISSN - 1099-0801
pISSN - 0269-3879
DOI - 10.1002/bmc.1260
Subject(s) - chromatography , chemistry , bioequivalence , selected reaction monitoring , electrospray ionization , pharmacokinetics , high performance liquid chromatography , mass spectrometry , tandem mass spectrometry , analyte , detection limit , analytical chemistry (journal) , pharmacology , medicine
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 ≥ 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. Copyright © 2009 John Wiley & Sons, Ltd.