Bernd Renger Consulting, Fritz-Reichle-Ring 2, 78315 Radolfzell, Germany.
J Chromatogr A. 2011 May 13;1218(19):2712-21. doi: 10.1016/j.chroma.2011.01.059. Epub 2011 Jan 27.
Analytical validation is a key requirement to asses and to prove a method's reliability and suitability for an intended use. Planar chromatographic procedures are used in different applications ranging from simple screening tests to sophisticated instrumental quantitative assays of analytes in complex matrices. This paper intends to give guidance on how to adopt international accepted formal requirements and guidelines for validation of these different TLC/HPTLC procedures. In addition, some selected parameters for robustness testing and for on going quality assurance of analytical performance based on control charts are reported.
分析验证是评估和证明方法可靠性以及适用于预期用途的关键要求。平面色谱程序用于不同的应用，从简单的筛选测试到复杂基质中分析物的复杂仪器定量分析。本文旨在提供如何采用国际公认的正式要求和指南来验证这些不同的 TLC/HPTLC 程序的指导。此外，还报告了一些用于稳健性测试和基于控制图的分析性能持续质量保证的选定参数。
