Validation for chromatographic and electrophoretic methods
Validation for chromatographic and electrophoretic methods
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DOI：
10.1590/s0100-40422004000500017
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发表时间：
2004-10-01
期刊：
影响因子：
--
通讯作者：
Melo, Lúcio Flávio Costa
中科院分区：
文献类型：
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作者：
Ribani, Marcelo;Bottoli, Carla Beatriz Grespan;Melo, Lúcio Flávio Costa
分析方法的验证是任何分析实验室实施质量控制系统的基础。由于气相色谱、高效液相色谱和毛细管电泳等分离技术通常是此类测定中使用的主要工具，因此有必要进行程序验证。本综述的目的是描述色谱和电泳分析验证的主要方面，以一般方式显示不同巴西和国际监管机构制定的指南之间的相似性和差异。
The validation of an analytical method is fundamental to implementing a quality control system in any analytical laboratory. As the separation techniques, GC, HPLC and CE, are often the principal tools used in such determinations, procedure validation is a necessity. The objective of this review is to describe the main aspects of validation in chromatographic and electrophoretic analysis, showing, in a general way, the similarities and differences between the guidelines established by the different Brazilian and international regulatory agencies.