Chapter 10 - Method Development and Validation of Capillary Electromigration Methods

Abstract

Capillary electromigration techniques are quite useful in various fields of analytical science. They may offer a different selectivity from chromatographic techniques and are therefore often a valuable complement toward existing techniques. Often, a given separation can only be achieved with an electromigration technique, which justifies a profound discussion of the strategy to follow during method development. Having seen the different separation mechanisms lying at the basis of the resolving power, the development of an electromigration method may require another approach than in chromatography. This chapter elaborates on the recent principles based on analytical Quality by Design and method life cycle management, to establish truly performing methods. It discusses in depth the various parameters that need to be optimized while developing a method. In addition, several aspects of method validation are discussed. Not only does every method need proof of good performance, this aspect is also extremely important in regulatory environments.