Novel LC–MS/MS method for the determination of selumetinib (AZD6244) in whole blood collected with volumetric absorptive microsampling

Ramakrishna R Voggu; Theodore S Brus; Chineta T Barksdale; Paul Severin; Patricia Hansen; Ross Chudnovskiy; Eric Thomas; Christopher Bailey

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Novel LC–MS/MS method for the determination of selumetinib (AZD6244) in whole blood collected with volumetric absorptive microsampling

机译：用容量吸收微内采样收集的全血中测定Selumetinib（AZD6244）的新型LC-MS / MS方法

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Aim: A method has been developed and validated for quantitation of selumetinib?in human whole blood collected using a Mitra? volumetric absorptive microsampling device. This device is patient-friendly, affording less-invasive sampling with broad applicability to clinical and diagnostic applications – specifically in pediatric populations. Materials & methods: In this method, drug is extracted from the Mitra?device via sonication in methanol: Ammonium hydroxide, then analyzed by LC–MS/MS. The linear range?for selumetinib analysis is 2.00–2000?ng/ml. Results: All validation parameters met acceptance criteria established in agreement with current regulatory guidance for bioanalytical method validation. The stability of selumetinib in Mitra?tips was established at both ambient and frozen conditions. Conclusion: A simple method has been developed and validated for determination of selumetinib from human whole blood, collected using volumetric absorptive microsampling?and analyzed by LC–MS/MS.

机译：目的：已经开发和验证了Selumetinib的定量方法的方法？在使用Mitra收集的人类全血？体积吸收微采样装置。该装置具有耐心友好的，提供较少的侵入性取样，具有广泛适用于临床和诊断应用 - 特别是在儿科人群中。材料和方法：在该方法中，通过在甲醇中的超声处理中从Mitra提取药物：氢氧化铵，然后通过LC-MS / MS分析。线性范围？对于Selumetinib分析为2.00-2000？ng / ml。结果：所有验证参数均符合生物分析方法验证的当前监管指南成立的验收标准。麦克拉姆替尼在Mitra稳定性ΔTips在周围和冷冻条件下建立了提示。结论：已经开发了一种简单的方法，用于测定人类全血的测定，采用体积吸收微内采样收集，并通过LC-MS / MS分析。

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来源
《Bioanalysis》 |2020年第13期|共10页
作者
Ramakrishna R Voggu; Theodore S Brus; Chineta T Barksdale; Paul Severin; Patricia Hansen; Ross Chudnovskiy; Eric Thomas; Christopher Bailey;
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作者单位

Covance Laboratories Inc;

Covance Laboratories Inc;

Covance Laboratories Inc;

Covance Laboratories Inc;

Covance Laboratories Inc;

Covance Laboratories Inc;

Covance Laboratories Inc;

Clinical Pharmacology &

Safety Sciences AstraZeneca Da Vinci Building;

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原文格式 PDF
正文语种 eng
中图分类生物科学;
关键词
AZD6244; LC–MS/MS; Mitra?; selumetinib; volumetric absorptive microsampling;

机译：AZD6244;LC-MS / MS;Mitra？;Selumetinib;体积吸收微采样;

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Novel LC–MS/MS method for the determination of selumetinib (AZD6244) in whole blood collected with volumetric absorptive microsampling

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