Validation of a bioanalytical method using capillary microsampling of 8 μl plasma samples: application to a toxicokinetic study in mice
Validation of a bioanalytical method using capillary microsampling of 8 μl plasma samples: application to a toxicokinetic study in mice
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DOI：
10.4155/bio.12.177
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发表时间：
2012-08-01
期刊：
影响因子：
1.8
通讯作者：
Konigsson, Kristian
中科院分区：
文献类型：
--
作者：
Jonsson, Ove;Villar, Rodrigo Palma;Konigsson, Kristian
背景：毛细管微量取样是最近推出的一项新技术，用于简化小量、精确体积液体基质的收集和处理。本文开发了一种生物分析方法，对 8 μl 血浆样品进行了充分验证，并将其应用于小鼠毒理学研究。结果：该方法在0.06-30μM浓度范围内得到验证。在动物设施中成功实施了采集32μl血液制备8μl血浆的程序。该方法和研究验证的所有结果均符合监管测定的要求。结论：结果表明，8μl 血浆微量样品的采样和分析具有一贯优异的准确度和精密度。血浆毛细管微量采样提供了将伦理、科学和经济效益结合起来的可能性，同时仍然保持血浆中药物暴露数据的优势。
Background: Capillary microsampling was recently introduced as a new technique for simplified collection and handling of small, exact volumes of liquid matrices. In this article, a bioanalytical method was developed and fully validated for 8 mu l plasma samples and applied to a toxicology study in mice. Results: The method was validated in the concentration range 0.06-30 mu M. A procedure where 32 mu l of blood was collected for preparation of 8 mu l plasma was successfully implemented at the animal facility. All the results for the method and study validation met the requirements of a regulated assay. Conclusion: It is shown that 8 mu l plasma microsamples can be sampled and analyzed with consistently excellent accuracy and precision. Capillary microsampling of plasma offers a possibility to combine ethical, scientific and economic benefits while still maintaining the advantage of having drug exposure data in plasma.