CLC number: R9
On-line Access: 2024-08-27
Received: 2023-10-17
Revision Accepted: 2024-05-08
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Ming-zhu HUANG, Jian-zhong SHENTU, Jun-chun CHEN, Jian LIU, Hui-li ZHOU. Determination of risperidone in human plasma by HPLC-MS/MS and its application to a pharmacokinetic study in Chinese volunteers[J]. Journal of Zhejiang University Science B, 2008, 9(2): 114-120.
@article{title="Determination of risperidone in human plasma by HPLC-MS/MS and its application to a pharmacokinetic study in Chinese volunteers",
author="Ming-zhu HUANG, Jian-zhong SHENTU, Jun-chun CHEN, Jian LIU, Hui-li ZHOU",
journal="Journal of Zhejiang University Science B",
volume="9",
number="2",
pages="114-120",
year="2008",
publisher="Zhejiang University Press & Springer",
doi="10.1631/jzus.B0710439"
}
%0 Journal Article
%T Determination of risperidone in human plasma by HPLC-MS/MS and its application to a pharmacokinetic study in Chinese volunteers
%A Ming-zhu HUANG
%A Jian-zhong SHENTU
%A Jun-chun CHEN
%A Jian LIU
%A Hui-li ZHOU
%J Journal of Zhejiang University SCIENCE B
%V 9
%N 2
%P 114-120
%@ 1673-1581
%D 2008
%I Zhejiang University Press & Springer
%DOI 10.1631/jzus.B0710439
TY - JOUR
T1 - Determination of risperidone in human plasma by HPLC-MS/MS and its application to a pharmacokinetic study in Chinese volunteers
A1 - Ming-zhu HUANG
A1 - Jian-zhong SHENTU
A1 - Jun-chun CHEN
A1 - Jian LIU
A1 - Hui-li ZHOU
J0 - Journal of Zhejiang University Science B
VL - 9
IS - 2
SP - 114
EP - 120
%@ 1673-1581
Y1 - 2008
PB - Zhejiang University Press & Springer
ER -
DOI - 10.1631/jzus.B0710439
Abstract: This study presents a rapid, specific and sensitive liquid chromatography/tandem mass spectrometry (LC-MS/MS) assay for determination of risperidone (RIS) in human serum using paroxetine as an internal standard (IS). An Alltima-C18 column (2.1 mm×100 mm, 3 μm) and a mobile phase consisting of 0.1% formic acid-acetonitrile (40:60, v/v) were used for separation. The analysis was performed by selected reaction monitoring (SRM) method, and the peak area of the m/z 411.3→191.1 transition for RIS was measured versus that of the m/z 330.1→192.1 transition for IS to generate the standard curves. The assay linearity of RIS was confirmed over the range 0.25~50.00 ng/ml and the limit of quantitation was 0.05 ng/ml. The linear range corresponds well with the serum concentrations of the analytes obtained in clinical pharmacokinetic studies. Intraday and interday relative standard deviations were 1.85%~9.09% and 1.56%~4.38%, respectively. The recovery of RIS from serum was in the range of 70.20%~84.50%. The method was successfully applied to investigate the bioequivalence between two kinds of tablets (test versus reference products) in 18 healthy male Chinese volunteers. The result suggests that two formulations are bioequivalent.
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