Validation of liquid chromatography mass spectrometry (LC-MS) methods
1. Validation: General
The procedure for demonstrating the reliability of analytical methods is called validation. Validation is required for all analytical methods, but the amount of work and complexity of the issues encountered increases with increasing sophistication of the technique used.
LC-MS is an extremely powerful and at the same time highly sophisticated technique. It offers various operation modes (scan, MRM, etc), numerous parameters and several possibilities of ionization (protonation, adduct formation, etc). However, these numerous possibilities come at a cost: LC-MS systems are complex and not always robust. Therefore it is extremely important that the reliability of LC-MS based analytical methods is assured and this is done by validating the method.
This section introduces the basics of validation and is divided into five subsections:
1.1. The purpose of validation
