Int. J. Metrol. Qual. Eng.
Volume 8, 2017
|Number of page(s)
|08 March 2017
Statistical tools and approaches to validate analytical methods: methodology and practical examples★
Laboratory of Biomolecules and Organic Synthesis, Department of Chemistry, Faculty of Sciences Ben M'Sik, University Hassan II of Casablanca,
Avenue Driss El Harti B.P 7955,
Sidi Othmane Casablanca, Morocco
⁎ Corresponding author: email@example.com
Accepted: 26 December 2016
The analyst needs to know whether the result of measurement can be accepted with confidence or, on the contrary, rejected because it is wrong. It is essential, also, to know whether an analysis method is suitable for the intended use. Likewise, it is more important for the researcher to know if he can trust a new developed method and what are the criteria to respect to ensure its validity. The statistical tools allow us to address all these points. The experimental protocol applied in this work is based on a common methodology, inspired by regulatory guidelines regarding statistical data analysis in analytical method validation, to optimize the number of assays and satisfy the study of validation criteria. In order to better understand the statistical analysis of raw data, practical examples are treated for quantify: an active ingredient in pharmaceutical drugs, a heavy metal in fishery products, and a drug in seizures.
Key words: statistical tests / analytical validation / quality control / measurement / stability
© S. Belouafa et al., published by EDP Sciences, 2017
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
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