Validation of analytical methods based on accuracy profiles

Validation is a very living field in analytical chemistry as illustrated by the numerous publications addressing this topic. But, there is some ambiguity in this concept and the abundant vocabulary often does not help the analytical chemist. This paper presents a new method based on the fitness-for-purpose approach of the validation. It consists in building a graphical decision-making tool, called the accuracy profile. Using measurements collected under reproducibility or intermediate precision condition, it allows computing an interval where a known proportion of future measurements will be located. When comparing this interval to an acceptability interval defined by the result end-user it is possible to simply decide whether a method is valid or not. The fundamentals of this method are presented starting from an accepted definition of validation. An example of application illustrates how validation can be experimentally organized and conclusion made. (c) 2007 Elsevier B.V. All rights reserved.