Specific guidelines and common experimental protocols for the validation of LC-MS methods are needed. However, existing guidelines are difficult to follow. The application fields involved are numerous, including the pharmaceutical, food, environmental, forensic and clinical ones. Therefore, the aim of this proposal is to review the present status of validation methods critically and provide a broader and easy to follow guide for the validation steps in all the aforementioned areas, with cross-references to definitions and further details. In particular, methods for calculating the detection and quantification limits, calibration, standards, matrix effect, recovery, reproducibility will be provided in an exemplified way. Moreover, we aim to study the best quality control (QC) strategies and External quality assurance (EQA) programs.
Method validation is the first critical step required as a necessary part of a comprehensive system of quality assurance in analytical chemistry but also in other fields of chemistry. The objective of the validation is to demonstrate that an analytical method is suitable, and traceable as far as possible, for its intended purpose. To date, numerous guidelines for the validation of analytical methods have been published (IUPAC Technical Report 2002 (https://doi.org/10.1351/pac200274050835), Eurachem 2014, EMA 2011, etc.), however there is still a need for updated and exemplified guidelines for LC-MS method validation and performance in scientific research. Indeed, the technological improvements that have occurred in the last decades for HPLC systems, MS ion sources and detectors should be considered in order to have an updated protocol.
This guideline is intended to provide an exemplified version of recommendations for the validation and performance of analytical assays in pharmaceutical, food, environmental, forensic and clinical fields, for chemical and biological drug quantification and their application in the analysis of the samples of interest. The quantification of uncertainty will be also addressed in a clear and practical manner.
The task group will be responsible for drafting a document in which an easy to follow guide will be drawn up that can support and motivate all those who work in this area to validate their methods. Moreover, report templates for the review of results and archiving will be studied and amended versions produced. This project will enhance the importance of already recognized IUPAC tools in method validation, providing a worldwide universal and harmonized language to the intended stakeholders.
Page last update 10 March 2022