Development and validation of a hydrophilic interaction liquid chromatography-tandem mass spectrometric method for the analysis of paroxetine in human plasma.

Development and validation of a hydrophilic interaction liquid chromatography-tandem mass spectrometric method for the analysis of paroxetine in human plasma.
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用于分析人血浆中帕罗西汀的亲水相互作用液相色谱-串联质谱方法的开发和验证。

DOI:
10.1002/bmc.288
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发表时间:
2004
期刊:
Biomedical chromatography : BMC
影响因子:
--
通讯作者:
Angela Eerkes
Angela Eerkes
中科院分区:
--
文献类型:
--
作者:
Nai;Angela Eerkes

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建立了一种灵敏、简便、快速、可靠的亲水相互作用液相色谱-串联质谱(HILIC-MS/MS)测定帕罗西汀的方法,并在0.050 ~ 50 ng/mL的曲线范围内进行了验证。这是首次发表的LC-MS/MS方法,该方法的定量下限比先前发表的方法低10倍。采用简单的液-液萃取法,以甲基叔丁基醚(MTBE)为萃取溶剂,从血浆中提取帕罗西汀和内标芬太尼-d(5)。提取液蒸发至干燥,重组并使用低水-高有机流动相注射到硅柱上。每次注射的色谱运行时间为2.0 min,帕罗西汀和IS的保留时间分别为1.1 min和1.2 min。通过监测m/z 330—> 192的帕罗西汀和m/z 342—> 188的IS进行检测。质量控制(QC)样品的日间精密度和准确度<5.0%相对标准偏差(RSD)和<2.9%相对误差(RE)。该方法可用于支持治疗药物监测和药代动力学或药物-药物相互作用的研究。
A sensitive, simple, fast and rugged hydrophilic interaction liquid chromatography-tandem mass spectrometry (HILIC-MS/MS) method for the determination of paroxetine was developed and validated over curve range 0.050-50 ng/mL using only 0.4 mL plasma. This is the first published LC-MS/MS method and the low limit of quantitation of this method is 10-fold lower than previously published methods. A simple liquid-liquid extraction method using methyl-tert butyl ether (MTBE) as the extraction solvent was used to extract paroxetine and the internal standard (IS) fentanyl-d(5) from plasma. The extract was evaporated to dryness, reconstituted and injected onto a silica column using a low aqueous-high organic mobile phase. The chromatographic run time was 2.0 min per injection, with retention times of 1.1 and 1.2 min for paroxetine and IS, respectively. The detection was by monitoring paroxetine at m/z 330 --> 192 and IS at m/z 342 --> 188, respectively. The inter-day precision and accuracy of the quality control (QC) samples were <5.0% relative standard deviation (RSD) and <2.9% relative error (RE). This method can be used for supporting therapeutical drug monitoring and pharmacokinetic or drug-drug interaction studies.