Ammerman Jennifer, Huang Chaoyang, Sailstad Jeffrey, Wieling Jaap, Whitmire Monica Lee, Wright Daniel, de Lisio Patricia, Keenan Fergus, McCurdy Ed, Woods Bert, Wang Phillip, Osredkar Anastasia, Ciaravino Jessica
MPI Research, 54943 N. Main Street, Mattawan, MI 49071, USA. jennifer.ammerman@ mpiresearch.com
Bioanalysis. 2013 Aug;5(15):1831-41. doi: 10.4155/bio.13.146.
This White Paper is focused on the technical aspects regarding quantifying pharmaceutically derived inorganic elements in biomatrices in support of GLP nonclinical and clinical studies using inductively coupled plasma (ICP) techniques. For decades ICP has been used in support of Environmental Protection Agency analyses and has more recently been applied for use in the pharmaceutical industry. Current bioanalytical method validation and sample analysis regulatory guidance applies to chromatographic platforms used for analysis of large- and small-molecule PK and TK assessments; however, it is not directly applicable to all aspects of various ICP techniques. Increasingly, quadrupole and high-resolution ICP-MS methods of analysis are being used to quantify inorganic elements contained in pharmaceutical compounds and biomatrices. Many elements occur endogenously in biomatrices, affecting quantification of blanks, standard curve samples, QC samples, and the selection of appropriate levels for the LLOQ.
本白皮书聚焦于使用电感耦合等离子体（ICP）技术对生物基质中药物衍生的无机元素进行定量分析的技术层面，以支持GLP非临床和临床研究。几十年来，ICP一直用于支持美国环境保护局的分析工作，最近已应用于制药行业。当前的生物分析方法验证和样品分析监管指南适用于用于分析大分子和小分子PK和TK评估的色谱平台；然而，它并不直接适用于各种ICP技术的所有方面。越来越多地，四极杆和高分辨率ICP-MS分析方法被用于定量药物化合物和生物基质中所含的无机元素。许多元素在生物基质中内源性存在，影响空白、标准曲线样品、QC样品的定量分析以及LLOQ合适水平的选择。
