Streamlining analytical method development with a focus on genotoxic impurities – Developing analytical methods for a range of genotoxic impurities

Development of chromatographic methods for the determination of genotoxic (GTI) or potential genotoxic (PGI) impurities can be time consuming and laborious. Having a generic approach to a method development strategy can aid in the generation of a suitable method in a shorter space of time. Several different approaches to method development are possible. This paper provides an overview of method development strategies to generate a suitable, reliable, robust, and even validatable method for the determination of genotoxic impurities. The discussion includes several examples of successfully developed and validated methods for a range of genotoxic impurities, including nitrosamines, by liquid chromatography (LC) and gas chromatography (GC).