Development and validation of a dried blood spot assay for the quantification of ribavirin using liquid chromatography coupled to mass spectrometry.
Development and validation of a dried blood spot assay for the quantification of ribavirin using liquid chromatography coupled to mass spectrometry.
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DOI：
10.1016/j.jchromb.2013.10.035
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发表时间：
2014-01-01
影响因子：
3
通讯作者：
Kiser, Jennifer J.
中科院分区：
文献类型：
--
作者：
Jimmerson, Leah C.;Zheng, Jia-Hua;Bushman, Lane R.;MacBrayne, Christine E.;Anderson, Peter L.;Kiser, Jennifer J.
用于测量药物的高效、廉价和灵敏的测定对于药代动力学和药效学（PK-PD）分析是感兴趣的。干血斑（DBS）是一种独特的生物分析基质，具有满足测量许多分析物的这种兴趣的潜力。在这里，我们描述了一个反相高效液相色谱（LC），串联质谱（MS/MS）测定利巴韦林（RBV）在DBS的开发和验证。使用同位素标记的内标物在甲醇中提取来自点样和干燥全血的3 mm穿孔物，用于LC-MS/MS分析。在0.05 μg/mL至10.0 μg/mL范围内进行验证，结果表明该方法具有精密度（变异系数≤ 15%）和准确度（在对照品的±15%范围内）。对于20- 54%的红细胞压积范围、中心与边缘冲孔以及10-60 μL的斑点体积，符合这些验收标准。RBV在室温和−20°C下以及三个冻融循环中可稳定长达140天。DBS与血浆中RBV的相关性产生r2 ≥ 0.98，表明DBS可用作人类受试者PK-PD研究中血浆的替代品。
Efficient, inexpensive and sensitive assays for the measurement of drugs are of interest for pharmacokinetic and pharmacodynamics (PK-PD) analysis. Dried blood spots (DBS) are a unique bioanaltyical matrix with the potential to fulfill this interest for the measurement of numerous analytes. Here we describe the development and validation of a reversed-phase high performance liquid chromatographic (LC), tandem mass spectrometry (MS/MS) assay for the determination of ribavirin (RBV) in DBS. A 3mm punch from spotted and dried whole blood was extracted in methanol utilizing isotopically labeled internal standard for LC-MS/MS analysis. Validation was performed over a range of 0.05 μg/mL to 10.0 μg/mL and the method was shown to be precise (coefficient of variation ≤ 15%) and accurate (within ±15% of control). These acceptance criteria were met for hematocrit ranges of 20-54%, for center versus edge punches and for spot volumes from 10-60 μL. RBV was stable for up to 140 days at room temperature and −20°C as well as for three freeze/thaw cycles. Correlation of RBV in DBS versus in plasma yielded r2 ≥ 0.98 demonstrating that DBS can be used as an alternative to plasma for PK-PD studies in human subjects.
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影响因子：
5
作者：
Holub, Margareta;Tuschl, Karin;Bodamer, Olaf A.
通讯作者：
Bodamer, Olaf A.
影响因子：
2
作者：
Liu, Guowen;Snapp, Heidi M.;Ji, Qin C.
通讯作者：
Ji, Qin C.
影响因子：
4.9
作者：
Durand-Gasselin, Lucie;Da Silva, David;Grassi, Jacques
通讯作者：
Grassi, Jacques
影响因子：
7.4
作者：
Matuszewski, BK;Constanzer, ML;Chavez-Eng, CM
通讯作者：
Chavez-Eng, CM
影响因子：
1.5
作者：
Castillo-Mancilla, Jose R.;Zheng, Jia-Hua;Anderson, Peter L.
通讯作者：
Anderson, Peter L.