Scope extension validation protocol: inclusion of analytes and matrices in an LC-MS/MS sulfonamide residues method

Abstract

Validation is a required process for analytical methods. However, scope extension, i.e. inclusion of more analytes, other matrices and/or minor changes in extraction procedures, can be achieved without a full validation protocol, which requires time and is laborious to the laboratory. This paper presents a simple and rugged protocol for validation in the case of extension of scope. Based on a previously reported method for analysis of sulfonamide residues using LC-MS/MS, inclusion of more analytes, metabolites, matrices and optimisation for the extraction procedure are presented in detail. Initially, the method was applied only to liver samples. In this work, milk, eggs and feed were also added to the scope. Several case-specific validation protocols are proposed for extension of scope.

Graphical Abstract

Keywords:

• sulfonamides
• tandem mass spectrometry
• validation
• residue analysis
• scope extension
• 2002/657/EC