Statistical tools and approaches to validate analytical methods: methodology and practical examples

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.