Development and validation of a volumetric absorptive microsampling- liquid chromatography mass spectrometry method for the analysis of cefepime in human whole blood: Application to pediatric pharmacokinetic study.
Development and validation of a volumetric absorptive microsampling- liquid chromatography mass spectrometry method for the analysis of cefepime in human whole blood: Application to pediatric pharmacokinetic study.
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用于分析人全血中头孢吡肟的体积吸收微量采样-液相色谱质谱法的开发和验证：在儿科药代动力学研究中的应用。
DOI：
10.1016/j.jpba.2019.113002
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发表时间：
2020
影响因子：
3.4
通讯作者：
Zuppa,AthenaF
中科院分区：
文献类型：
--
作者：
Moorthy,GaneshS;Vedar,Christina;Zane,NicoleR;Downes,KevinJ;Prodell,JaniceL;DiLiberto,MaryAnn;Zuppa,AthenaF
头孢吡肟是第四代头孢菌素类抗生素，对许多革兰氏阳性菌和革兰氏阴性菌具有广谱活性。越来越需要开发灵敏的小体积测定，沿着侵入性较小的样品收集，以促进儿科药代动力学临床试验和治疗药物监测。容量吸收微量取样（VAMS™）方法可准确、精确地采集固定体积的血液（10 μL），减少或消除与干血点样技术相关的容量血液红细胞压积测定偏倚。建立了高效液相色谱-串联质谱法测定头孢吡肟的方法。采用从VAMS™装置提取样品，然后使用串联质谱进行反相色谱分离和选择性检测，每个样品运行4分钟。头孢吡肟在0.1 ~ 100 μg/mL范围内线性关系良好。基于3天验证研究，日内和日间准确度在95.4-113%范围内，精密度（CV）<15%。头孢吡肟的回收率为40.8 ~ 62.1%，基质效应为89.5-96.7%。在试验条件下（室温下3 h，提取后在自动进样器中24 h），头孢吡肟在人全血中保持稳定。头孢吡肟在4 °C下至少稳定1周（7天），在−20 °C下稳定1个月（39天），在−78 °C下稳定3个月（91天）。该方法提供了一种有效的定量头孢吡肟，并成功地实施了在儿科临床试验中的全血微量样品的分析。
Cefepime is a fourth-generation cephalosporin antibiotic with an extended spectrum of activity against many Gram-positive and Gram-negative bacteria. There is a growing need to develop sensitive, small volume assays, along with less invasive sample collection to facilitate pediatric pharmacokinetic clinical trials and therapeutic drug monitoring. The volumetric absorptive microsampling (VAMS™) approach provides an accurate and precise collection of a fixed volume of blood (10 μL), reducing or eliminating the volumetric blood hematocrit assay-bias associated with the dried blood spotting technique. We developed a high-performance liquid chromatographic method with tandem mass spectrometry detection for quantification of cefepime. Sample extraction from VAMS™ devices, followed by reversed-phase chromatographic separation and selective detection using tandem mass spectrometry with a 4 min runtime per sample was employed. Standard curves were linear between 0.1–100 μg/mL for cefepime. Intra- and inter-day accuracies were within 95.4–113% and precision (CV) was < 15 % based on a 3-day validation study. Recoveries ranged from 40.8 to 62.1% and the matrix effect was within 89.5–96.7% for cefepime. Cefepime was stable in human whole blood under assay conditions (3 h at room temperature, 24 h in autosampler post-extraction). Cefepime was also stable for at least 1 week (7 days) at 4 °C, 1 month (39 days) at −20 °C and 3 months (91 days) at −78 °C as dried microsamples. This assay provides an efficient quantitation of cefepime and was successfully implemented for the analysis of whole blood microsamples in a pediatric clinical trial.
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影响因子：
6.2
作者：
De Kesel, Pieter M. M.;Lambert, Willy E.;Stove, Christophe P.
通讯作者：
Stove, Christophe P.
头孢吡肟治疗药物监测的液相色谱-串联质谱分析
影响因子：
--
作者：
G. Moorthy;K. Downes;Nicole R. Zane;A. Zuppa
通讯作者：
A. Zuppa
DOI：
10.1016/j.jpba.2018.04.001
发表时间：
2018-07-15
影响因子：
3.4
作者：
Xie, Iris;Xu, Yang;Bateman, Kevin P.
通讯作者：
Bateman, Kevin P.
影响因子：
4.9
作者：
Bugnon, D;Giannoni, E;Moreillon, P
通讯作者：
Moreillon, P
影响因子：
1.8
作者：
Spooner, Neil;Denniff, Philip;Rudge, James B.
通讯作者：
Rudge, James B.