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Determination of penciclovir in human plasma by liquid chromatography–electrospray ionization tandem mass spectrometry: application to a clinical pharmacokinetic study

机译:液相色谱-电喷雾串联质谱法测定人血浆中的喷昔洛韦:在临床药代动力学研究中的应用

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摘要

A rapid, specific and sensitive liquid chromatography tandem mass spectrometry (LC–MS/MS) method was developed for the determination of penciclovir in human plasma. The method involved simple, one-step SPE procedure coupled with a C18, 75 × 4.mm, 3μm column with a flow-rate of 0.5?mL/min, and acyclovir was used as the internal standard. The Quattro Micro mass spectrometry was operated under the multiple reaction-monitoring mode using the electrospray ionization technique. Using 250?μL plasma, the methods were validated over the concentration range 52.555–6626.181?ng/mL, with a lower limit of quantification of 52.55?ng/mL. The intra- and inter-day precision and accuracy values were found to be within the assay variability limits as per the FDA guidelines. The developed assay method was applied to a clinical pharmacokinetic study in human volunteers. Copyright ? 2010 John Wiley & Sons, Ltd.
机译:建立了一种快速,特异性和灵敏的液相色谱串联质谱法(LC-MS / MS),用于测定人血浆中的喷昔洛韦。该方法涉及简单的一步SPE流程,结合C 18 ,75×4.mm,3μm色谱柱,流速为0.5?mL / min,使用阿昔洛韦作为内部标准。 Quattro Micro质谱仪使用电喷雾电离技术在多反应监测模式下运行。使用250 µL血浆,在52.555–6626.181?ng / mL的浓度范围内对方法进行了验证,定量下限为52.55?ng / mL。根据FDA指南,发现日内和日间精度和准确度值均在分析变异性范围内。所开发的测定方法已应用于人类志愿者的临床药代动力学研究。版权? 2010 John Wiley&Sons,Ltd.

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