GCxGC for pharmaceutical applications: Investigation of complex drugs (Thomas Gröger, MDCW 2023)

🎤 Presenter: Lukas Schwalb¹´², Ole Tiemann¹, Thomas Gröger², Christopher Rüger¹, Ralf Zimmermann¹ (¹University of Rostock, Chair of Analytical Chemistry, Joint Mass Spectrometry Centre (JMSC), Rostock, Germany. 2Helmholtz Munich, Comprehensive Molecular Analytics” (CMA), Joint Mass Spectrometry Centre (JMSC), Munich, Germany)

Abstract

GC×GC has been used for more and more applications since its introduction in the 1980s. While it has become routine in areas such as fossil fuels and environmental studies, and is at least an integral part of research in other areas, its use in other areas is virtually undocumented. One of these areas is the analysis of pharmaceuticals. Not only is there still no harmonized method based on GC×GC used in the pharmaceutical industry, but also just very isolated proof-of-concept studies that can be found in the scientific literature.

In the first part of the presentation, we will briefly summarize the studies published so far and discuss possible reasons why GC×GC has not yet become established in the pharmaceutical field. In the second part, we will present a recent study in which GC×GC-high-resolution mass spectrometry was used to investigate the active pharmaceutical ingredient (API) sodium bituminosulfonate (SBS). The pharmaceuticals with the API SBS can tentatively be counted among the class of non-biological complex drugs (NBCD). Therefore, by definition, SBS cannot be comprehensively investigated by a single or -combined physiochemical method so far.

The results of our study show the advantages of the application of GC×GC but also its complexity. Special attention is given to the use of GC×GC for non-targeted analysis and the demands this implies in terms of method validation when the method is to be applied in the pharmaceutical field.