Is it really necessary to validate an analytical method or not? That is the question
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Other documents of the author: Rambla Alegre, María; Esteve-Romero, Josep; Carda-Broch, Samuel
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comunitat-uji-handle2:10234/7013
comunitat-uji-handle3:10234/8638
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http://dx.doi.org/10.1016/j.chroma.2011.10.050 |
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Title
Is it really necessary to validate an analytical method or not? That is the questionDate
2012Publisher
ElsevierISSN
0021-9673; 1873-3778Bibliographic citation
Journal of Chromatography A Volume 1232, 6 April 2012, Pages 101–109 Selected Papers from the 36th International Symposium on High-Performance Liquid Phase Separations and Related TechniquesType
info:eu-repo/semantics/articlePublisher version
http://www.sciencedirect.com/science/article/pii/S0021967311015743Version
info:eu-repo/semantics/publishedVersionSubject
Abstract
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 ... [+]
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. [-]
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Journal of Chromatography A, 2012, Vol. 1232. Selected Papers from the 36th International Symposium on High-Performance Liquid Phase Separations and Related TechniquesRights
Copyright © 2011 Elsevier B.V. All rights reserved.
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