一种用于测定人血浆中蒿甲醚及其代谢物双氢青蒿素的液相色谱-串联质谱法。
A liquid chromatographic-tandem mass spectrometric method for determination of artemether and its metabolite dihydroartemisinin in human plasma.
作者信息
Hanpithakpong Warunee, Kamanikom Benjamas, Singhasivanon Pratap, White Nicholas J, Day Nicholas Pj, Lindegardh Niklas
机构信息
Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.
出版信息
Bioanalysis. 2009 Apr;1(1):37-46. doi: 10.4155/bio.09.6.
BACKGROUND
Artemether-lumefantrine is the most widely recommended artemisinin-based combination treatment for falciparum malaria. Quantification of artemether and its metabolite dihydroartemisinin in biological matrices has traditionally been difficult, with sensitivity being an issue.
RESULTS
A high-throughput bioanalytical method for the analysis of artemether and its metabolite dihydroartemisinin in human plasma using solid-phase extraction in the 96-well plate format and liquid chromatography coupled to positive ion mode tandem mass spectroscopy has been developed and validated according to US FDA guidelines. The method uses 50 µl plasma and covers the calibration range 1.43-500 ng/ml with a limit of detection at 0.36 ng/ml.
CONCLUSIONS
The developed liquid chromatography-tandem mass spectrometry assay is more sensitive than all previous methods despite using a lower plasma volume (50 µl) and is highly suitable for clinical studies where plasma volumes are limited, such as pediatric trials.
背景
蒿甲醚-本芴醇是最广泛推荐的用于治疗恶性疟的青蒿素类复方疗法。传统上，对生物基质中的蒿甲醚及其代谢物双氢青蒿素进行定量分析一直很困难，灵敏度是一个问题。
结果
已开发出一种高通量生物分析方法，该方法采用96孔板形式的固相萃取以及液相色谱-正离子模式串联质谱法来分析人血浆中的蒿甲醚及其代谢物双氢青蒿素，并已根据美国食品药品监督管理局（US FDA）的指南进行了验证。该方法使用50微升血浆，校准范围为1.43-500纳克/毫升，检测限为0.36纳克/毫升。
结论
尽管使用的血浆体积较小（50微升），但所开发的液相色谱-串联质谱分析法比以往所有方法都更灵敏，非常适合血浆量有限的临床研究，如儿科试验。
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