Validation of analytical methods: the international requirements

Abstract

Analytical method is the most important part of chemical analysis, an action guide for the analyst and carrier of information about the metrological characteristics. To confirm the parameters and legitimize the methodology, Russian specialists traditionally use the procedure of metrological certification in accordance with GOST 8.563-2009. Validation of analytical procedures or analytical methods is a concept recently accepted in Russia and causes confusion in many domestic experts. However, this internationally accepted concept is actively used for long to assure the quality of chemical analysis. The European Community for Metrology in Analytical Chemistry (Eurachem) has developed a guide to validation of analytical methods «The Fitness for Purpose of Analytical Methods»; many articles have been published on this issue. This article is devoted to generalization of the similar features and individual differences in certification, validation and verification of the methods of chemical analysis. Metrological characteristics of the analytical methods are also considered. An emphasis is made on the procedure of estimating the uncertainty as the most important stage in the development and validation of the analytical method.