采用液相色谱-串联质谱法对通过体积吸收微量采样收集的全血中的艾美司他（ACU-4429）进行生物分析。
Bioanalysis of emixustat (ACU-4429) in whole blood collected with volumetric absorptive microsampling by LC-MS/MS.
作者信息
Miao Zhixin, Farnham James G, Hanson Glenn, Podoll Terry, Reid Michael J
机构信息
Covance Laboratories, Inc., 3301 Kinsman Blvd., Madison, WI 53704, USA.
Acucela, Inc., 21720 23rd Drive SE, Suite 120, Bothell, WA 98021, USA.
出版信息
Bioanalysis. 2015;7(16):2071-83. doi: 10.4155/bio.15.125.
BACKGROUND
A method to quantify emixustat (an investigational drug agent) in human blood collected using volumetric absorptive microsampling (VAMS) could be more practical for sample collection at sites with limited facilities for processing and storage of plasma.
METHODS
A LC-MS/MS method was developed and evaluated for accuracy and precision, linearity, carryover, selectivity, recovery, matrix effects, hematocrit effects and stability.
RESULTS
Core validation parameters met acceptance criteria within the normal ranges of hematocrit levels for adults (30-55%). Stability of emixustat in blood collected with and without anticoagulant (NaF/KOx) on the VAMS device at ambient, refrigerated and frozen conditions was established.
CONCLUSION
The method has been validated and is suitable for the bioanalysis of emixustat in human blood collected by VAMS.
背景
对于在血浆处理和储存设施有限的场所进行样本采集而言，一种用于定量使用体积吸收微采样（VAMS）收集的人血中艾美司他（一种研究用药物）的方法可能更为实用。
方法
开发了一种液相色谱-串联质谱（LC-MS/MS）方法，并对其准确性、精密度、线性、残留、选择性、回收率、基质效应、血细胞比容效应和稳定性进行了评估。
结果
在成人血细胞比容水平的正常范围内（30%-55%），核心验证参数符合验收标准。确定了艾美司他在VAMS装置上采集的有抗凝剂（氟化钠/草酸钾）和无抗凝剂血液中，在环境温度、冷藏和冷冻条件下的稳定性。
结论
该方法已得到验证，适用于VAMS采集的人血中艾美司他的生物分析。
Zotero 插件