A UPLC-MS/MS method for quantification of 5 alpha-androst-3 beta, 5,6 beta-triol in human plasma: development, validation and its application in clinical pharmacokinetic study

摘要

Aim: 5 alpha-androst-3 beta, 5,6 beta-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 5 alpha-androst-3 beta, 5,6 beta-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 (R) Acquity (TM) BEH C-18 column (2.1 x 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 5 alpha-androst-3 beta, 5,6 beta-triol and applied to investigate its plasma pharmacokinetic profiles in healthy Chinese subjects.