Drug development; Drug discovery; High throughput; Impurity profiling; Method validation; Supercritical fluid chromatography; Chemical Engineering (all)
Abstract :
[en] Abstract The purpose of this chapter is to provide a brief overview of the past, present, and future applications of supercritical fluid chromatography (SFC) in pharmaceutical drug discovery and development. In the first part of this chapter, various examples are provided, showing how SFC has been used in the past. Originally employed for the analysis of apolar compounds, SFC rapidly became an interesting tool to substitute NPLC for chiral separations, due to its higher efficiency, faster analysis times, reduced environmental impact, and lower costs. Developments in the early 2000s begun exploring the usefulness of SFC also for achiral analyses, but the instrumentation available was not capable to meet the well-established robustness and sensitivity criteria used in liquid and gas chromatography, thus discouraging its implementation in pharmaceutical analysis. However, the introduction of ultra-high-performance supercritical fluid chromatography (UHPSFC) systems from 2012 has played a key role in refueling interest in this technique. With better instrumentation, UHPSFC demonstrated very promising results in the pharmaceutical industry also in the context of achiral separations, from the impurity profiling of synthetic APIs to its implementation in more challenging contexts, such as peptide analysis. In the second part of the chapter, considerations on the SFC stationary and mobile phases, its coupling to detectors (especially MS), and performance in the context of method validation are discussed. The recent evolution of SFC has depicted an image of this technique being efficient, fast, complementary to liquid chromatography (LC), and able to satisfy different validation criteria. Finally, an interesting perspective for SFC is linked to its implementation in multidimensional systems, with the aim to expand chromatographic selectivity.
Research Center/Unit :
CIRM - Centre Interdisciplinaire de Recherche sur le Médicament - ULiège
Disciplines :
Chemistry Pharmacy, pharmacology & toxicology
Author, co-author :
Losacco, Gioacchino Luca; School of Pharmaceutical Sciences, University of Geneva, CMU, Geneva, Switzerland ; Institute of Pharmaceutical Sciences of Western Switzerland, University of Geneva, CMU, Geneva, Switzerland ; Analytical Research and Development, MRL, Merck & Co, Inc., Rahway, United States
Dispas, Amandine ; Université de Liège - ULiège > Unités de recherche interfacultaires > Centre Interdisciplinaire de Recherche sur le Médicament (CIRM)
Veuthey, Jean-Luc; School of Pharmaceutical Sciences, University of Geneva, CMU, Geneva, Switzerland ; Institute of Pharmaceutical Sciences of Western Switzerland, University of Geneva, CMU, Geneva, Switzerland
Guillarme, Davy; School of Pharmaceutical Sciences, University of Geneva, CMU, Geneva, Switzerland ; Institute of Pharmaceutical Sciences of Western Switzerland, University of Geneva, CMU, Geneva, Switzerland
Language :
English
Title :
Application space for SFC in pharmaceutical drug discovery and development
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