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采用超高效液相色谱-串联质谱法测定人血浆中的多奈哌齐。

Determination of donepezil in human plasma using ultra performance liquid chromatography-tandem mass spectrometry.

作者信息

Jeong Hyeon-Cheol, Park Jeong-Eun, Hyun Ji-Yeon, Park Min-Kyu, Shin Dong-Seong, Shin Kwang-Hee

机构信息

College of Pharmacy, Research Institute of Pharmaceutical Sciences, Kyungpook National University, Daegu 41566, Korea.

Dong-A University Hospital, Busan 49201, Korea.

出版信息

Transl Clin Pharmacol. 2018 Jun;26(2):64-72. doi: 10.12793/tcp.2018.26.2.64. Epub 2018 Jun 18.

DOI:10.12793/tcp.2018.26.2.64
PMID:32055551
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6989263/
Abstract

An ultra performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) method was developed and validated for the quantification of donepezil in human plasma. Donepezil and donepezil-D4 were extracted from human plasma by liquid-liquid extraction using a mixture of hexane and ethyl acetate (70:30 v/v). The extracted samples were analyzed using a Thermo Hypersil Gold C18 column with 5% acetic acid in 20 mM ammonium acetate buffer (pH 3.3) and 100% acetonitrile as a mobile phase with the 60:40 (v:v) isocratic method, at a flow rate of 0.3 mL/min. The injection volume was 3 µL, and the total run time was 3 min. Inter- and intra-batch accuracies ranged from 98.0% to 110.0%, and the precision was below 8%. The developed method was successfully applied to the quantification of donepezil in human plasma. The mean (standard deviation) maximum concentration and the median (range) time to maximum concentration were 8.6 (2.0) ng/mL and 2.0 h (1.0~5.0 h), respectively, in healthy Koreans after oral administration of 5 mg donepezil.

摘要

建立了一种超高效液相色谱-串联质谱（UPLC-MS/MS）法并进行了验证，用于定量测定人血浆中的多奈哌齐。多奈哌齐和多奈哌齐-D4通过液液萃取从人血浆中提取，萃取剂为己烷和乙酸乙酯的混合物（体积比70:30）。萃取后的样品使用Thermo Hypersil Gold C18柱进行分析，流动相为含5%乙酸的20 mM乙酸铵缓冲液（pH 3.3）和100%乙腈，采用60:40（v:v）等度洗脱法，流速为0.3 mL/min。进样体积为3 μL，总运行时间为3 min。批间和批内准确度在98.0%至110.0%之间，精密度低于8%。所建立的方法成功应用于人血浆中多奈哌齐的定量测定。在健康韩国人口服5 mg多奈哌齐后，平均（标准差）最大浓度和中位（范围）达峰时间分别为8.6（2.0）ng/mL和2.0 h（1.0~5.0 h）。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e243/6989263/e55a4fa26b77/tcp-26-64-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e243/6989263/4b115fcdbc80/tcp-26-64-g001.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e243/6989263/71598554fd4e/tcp-26-64-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e243/6989263/e55a4fa26b77/tcp-26-64-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e243/6989263/4b115fcdbc80/tcp-26-64-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e243/6989263/2306a91e5314/tcp-26-64-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e243/6989263/ea4cc5c6a85c/tcp-26-64-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e243/6989263/71598554fd4e/tcp-26-64-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e243/6989263/e55a4fa26b77/tcp-26-64-g005.jpg

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