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Development and validation of a UPLC-MS/MS method for simultaneous determination of LBPT and its metabolites in human plasma.

作者信息

Wu Mengyi, Liu Aijing, Zhuang Quankun, Jia Ranran, Zhou Yinping, Liu Yali, Wang Hongyun

机构信息

Clinical Pharmacology Research Center, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences, Beijing 100032, PR China.

Beijing Shiqiao Biological Pharmaceutical Co. Ltd, Beijing 101301, PR China.

出版信息

Bioanalysis. 2020 Feb;12(4):211-220. doi: 10.4155/bio-2019-0289. Epub 2020 Feb 21.

DOI:10.4155/bio-2019-0289
PMID:32083490
Abstract

A UPLC-MS/MS method was developed to determine LBPT as well as its four metabolites in human plasma to support the clinical study aiming to evaluate the efficacy of LBPT tablet in patients undergoing hip/knee replacement. Plasma samples were prepared by protein precipitation and then separated on a C analytical column using (A) acetonitrile (B) 0.1% formic acid and 10 mM ammonium formate in water. The detection was performed on a triple quadrupole tandem mass spectrometer in positive electrospray ionization using multiple reactions monitoring mode. The method has been validated in accordance with the US FDA guidelines and was applied to the measurement of five analytes in human plasma samples from a Phase II clinical trial.

摘要

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