期刊
JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES
卷 878, 期 24, 页码 2280-2285出版社
ELSEVIER SCIENCE BV
DOI: 10.1016/j.jchromb.2010.06.036
关键词
UPLC-MS/MS; Levosulpiride; Human plasma; Pharmacokinetic study; Bioanalytical method validation
资金
- Ministry of Health & Welfare, and the Republic of South Korea [A050584]
- Korea Health Promotion Institute [A050584] Funding Source: Korea Institute of Science & Technology Information (KISTI), National Science & Technology Information Service (NTIS)
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 BEN C-18 column with a mobile phase of ammonium formate buffer (1 mM, 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 200 ng/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. (C) 2010 Elsevier B.V. All rights reserved.
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