A UPLC-MS/MS method for quantification of 5α-androst-3β,5,6β-triol in human plasma: development, validation and its
Zhenlei Wang1, Huanhuan Wang1, Pei Hu1
1Phase I Unit, Clinical Pharmacology Research Center, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences, Beijing 100032, China.
Aim:
5α-androst-3β,5,6β-triol is a novel ischemic stroke drug under clinical development. The objective of this study was to develop and validate a simple ultraperformance liquid chromatography tandem mass spectrometry method for 5α-androst-3β,5,6β-triol in human plasma and its application in clinical pharmacokinetic study. Methodology & results: After being pretreated using an automatized solid-phase extraction procedure, plasma sample was separated on a Waters® Acquity™ BEH C18 column (2.1 × 50 mm id, 1.7 mm) by an Acquity UPLC system and detected by an API 5500 triple quadrupole mass spectrometer, which was validated following international guidelines.
Conclusion:
A simple method was successfully validated over a concentration range of 2.00-500 ng/ml for 5α-androst-3β,5,6β-triol and applied to investigate its plasma pharmacokinetic profiles in healthy Chinese subjects.
