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

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INTRODUCTION
The development of chromatographic methods to determine potential genotoxic impurities (GTIs) can be time consuming and laborious. While there are several approaches to method development (1), having a generic method development strategy can help streamline the process. This article provides an overview of method development strategies to help analysts, chromatographers, and researchers develop suitable, reliable, robust, and potentially validatable methods to determine GTIs. It includes several examples of successfully developed and validated methods for a range of GTIs, including nitrosamines, by liquid chromatography (LC) and gas chromatography (GC).