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比较色谱-质谱法研究抗逆转录病毒药物奈韦拉平在人血浆测定中的分析性能特征。

Comparative chromatography-mass spectrometry studies on the antiretroviral drug nevirapine-analytical performance characteristics in human plasma determination.

机构信息

University of Botswana, Department of Chemistry, Faculty of Science, PB UB 00704 Gaborone, Botswana.

University of Botswana, Department of Chemistry, Faculty of Science, PB UB 00704 Gaborone, Botswana.

出版信息

J Chromatogr B Analyt Technol Biomed Life Sci. 2014 Jan 15;945-946:101-9. doi: 10.1016/j.jchromb.2013.11.046. Epub 2013 Nov 28.

Abstract

A contrast between the analytical performance characteristics using gas chromatography-mass spectrometry (GC-MS) liquid chromatography-mass spectrometry (LC-MS) and liquid chromatography-ultraviolet (LC-UV) detection for the determination of the antiretroviral drug (ARV) nevirapine (NVP) in fortified human plasma after QuEChERS extraction has been made. Analytical performance characteristics, i.e. linearities, instrument detection limits (IDLs), limits of quantitation (LOQs), method detection limits (MDLs), % mean recoveries and the corresponding relative standard deviations (%RSDs) were estimated using techniques above. Using GC-MS, the correlation coefficients (r(2)) were ≥0.990, which were deemed acceptable linearities. The MDLs ranged between 11.1-29.8μg/L and 13.7-36.0μg/L using helium and hydrogen carrier gases respectively. The LOQs ranged between 16.5-66.7μg/L and 28.4-98.7μg/L using helium and hydrogen carrier gases respectively with a % mean recovery of 83% and %RSD of 4.6%. Using LC-MS and LC-UV, the correlation coefficients (r(2)) were ≥0.990. The MDLs were ranged between 3.14 and 47.1μg/L. The LOQs ranged between 2.85 and 90.0μg/L respectively. The MDLs using GC-MS, LC-MS and LC-UV were below the therapeutic range for NVP in human plasma is considered to be between 2300μg/L (Cmin) and 8000μg/L (Cmax). This study also demonstrated that helium can be substituted with hydrogen which is relatively cheaper and easily obtainable even by use of a generator.

摘要

已经对使用气相色谱-质谱(GC-MS)、液相色谱-质谱(LC-MS)和液相色谱-紫外(LC-UV)检测进行了对比,以确定在 QuEChERS 提取后测定强化人血浆中抗逆转录病毒药物(ARV)奈韦拉平(NVP)的分析性能特征。使用上述技术估计了分析性能特征,即线性、仪器检测限(IDL)、定量限(LOQ)、方法检测限(MDL)、%平均回收率和相应的相对标准偏差(%RSD)。使用 GC-MS,相关系数(r(2))≥0.990,被认为是可接受的线性。氦气和氢气载气的 MDL 分别为 11.1-29.8μg/L 和 13.7-36.0μg/L。氦气和氢气载气的 LOQ 分别为 16.5-66.7μg/L 和 28.4-98.7μg/L,平均回收率为 83%,RSD 为 4.6%。使用 LC-MS 和 LC-UV,相关系数(r(2))≥0.990。MDL 在 3.14-47.1μg/L 之间。LOQ 分别在 2.85-90.0μg/L 之间。GC-MS、LC-MS 和 LC-UV 的 MDL 均低于人血浆中 NVP 的治疗范围,被认为在 2300μg/L(Cmin)至 8000μg/L(Cmax)之间。本研究还表明,氦气可以用相对便宜且易于获得的氢气代替,甚至可以使用发生器获得氢气。

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