Àrea de Química Analítica, QFA, Universitat Jaume I, 12071 Castelló, Spain.
J Chromatogr A. 2012 Apr 6;1232:101-9. doi: 10.1016/j.chroma.2011.10.050. Epub 2011 Oct 28.
Method validation is an important requirement in the practice of chemical analysis. However, awareness of its importance, why it should be done and when, and exactly what needs to be done, seems to be poor amongst analytical chemists. Much advice related to method validation already exists in the literature, especially related to particular methods, but more often than not is underused. Some analysts see method validation as something that can only be done by collaborating with other laboratories and therefore do not go about it. In addition, analysts' understanding of method validation is inhibited by the fact that many of the technical terms used in the processes for evaluating methods vary in different sectors of analytical measurement, both in terms of their meaning and the way they are determined. Validation applies to a defined protocol, for the determination of a specified analyte and range of concentrations in a particular type of test material, used for a specified purpose. In general, validation should check that the method performs adequately for the purpose throughout the range of analyte concentrations and test materials to which it is applied. It follows that these features, together with a statement of any fitness-for-purpose criteria, should be completely specified before any validation takes place.
方法验证是化学分析实践中的一项重要要求。然而，分析化学家似乎对其重要性、为何要进行方法验证以及何时进行方法验证以及具体需要做什么认识不足。许多与方法验证相关的建议已经在文献中存在，特别是与特定方法相关，但往往未被充分利用。一些分析人员将方法验证视为只能与其他实验室合作才能完成的事情，因此他们不进行方法验证。此外，分析人员对方法验证的理解受到以下事实的限制，即在评估方法的过程中使用的许多技术术语在分析测量的不同领域中，无论是在含义还是确定方式上都有所不同。验证适用于针对特定类型的测试材料中特定分析物和浓度范围的明确定义的协议，用于特定目的。一般来说，验证应检查该方法在应用于分析物浓度和测试材料的整个范围内是否能充分满足目的。因此，在进行任何验证之前，这些特征以及任何适用性标准的说明都应完全指定。
