Validating a method dating rumors

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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 26 December 2016 Abstract 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.

The intent of method validation is to provide scientific evidence that the analytical method is reliable and consistent before it can be used in routine analysis of product.The analytical method validation is governed by the International Conference on Harmonization (ICH) [1,2].The key criteria for evaluation of an analytical method are: specificity, accuracy, precision, detection limit, quantitation limit, sensitivity, working range and linearity, robustness and recovery [3,4].The ICH definitions for validation characteristics are indexed in Table 1.The type of method and analytical technique used will determine the nature and extent of the validation studies required.

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