Are analysts doing method validation in liquid chromatography?
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Other documents of the author: Ruiz Ángel, M. J.; García Álvarez-Coque, M. C.; Berthod, A.; Carda-Broch, Samuel
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Show full item recordcomunitat-uji-handle:10234/9
comunitat-uji-handle2:10234/7013
comunitat-uji-handle3:10234/8638
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10.1016/j.chroma.2014.05.052 |
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Title
Are analysts doing method validation in liquid chromatography?Date
2015-06-22xmlui.dri2xhtml.METS-1.0.item-edition
Copyright © 2014 Elsevier B.V. All rights reserved.ISSN
0021-9673Type
info:eu-repo/semantics/articlePublisher version
http://www.sciencedirect.com/science/article/pii/S0021967314008188Version
info:eu-repo/semantics/publishedVersionSubject
Abstract
Method validation is being applied in the reported analytical methods for decades. Even before this protocol was defined, authors already somehow validated their methods without full awareness. They wished to assure ... [+]
Method validation is being applied in the reported analytical methods for decades. Even before this protocol was defined, authors already somehow validated their methods without full awareness. They wished to assure the quality of their work. Validation is an applied approach to verify that a method is suitable and rugged enough to function as a quality control tool in different locations and times. The performance parameters and statistical protocols followed throughout a validation study vary with the source of guidelines. Before single laboratory validation, an analytical method should be fully developed and optimized. The purpose of the validation is to confirm performance parameters that are determined during method development, and it should provide information on how the method will perform under routine use. An unstable method may require re-validation. Further method development and optimization will be needed if validation results do not meet the accepted performance standards. When possible, the validation protocol should also be conducted as a collaborative study by multiple laboratories, on different instruments, reagents, and standards. At this point, it would be interesting to know how people are validating their methods. Are they evaluating all defined validation parameters? Are they indicating the followed guidelines? Is re-validation really currently used? Is validation performed by a single laboratory, or is it a collaborative work by several laboratories? Is it an evolving discipline? In this survey, we will try to answer these questions focused to the field of liquid chromatography. [-]
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Journal of Chromatography A, 2014, 1353: 2-9Rights
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