Chapter 16 – Pharmaceutical Applications

Supercritical fluid chromatography (SFC) has already become an important complementary technique in separation science due to its high speed, efficiency, and versatility in method development. Its use has been adopted also at various stages of the drug development including three main fields: the drug discovery, quality control of drug substances, and drug products and clinical analysis (bioanalysis). For the latter it is of key importance to provide sensitive and selective determination of drugs and their metabolites in biological material. Therefore SFC coupled to sensitive mass spectrometry detection has become a method of choice. However, the extent of use of SFC in different stages of drug development differs quite substantially. While it is already well-established and widely used in enantioseparation and purification tasks, its use in impurity profiling and clinical applications has only become interesting recently and such studies have started to appear more significantly since about 2012.