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Defining a system suitability limit to decide on column deterioration and to facilitate column transfers in chiral supercritical fluid chromatography

Tijdschriftbijdrage - Tijdschriftartikel

The separation of enantiomers is an important requirement during the entire drug life cycle in the pharmaceutical industry. High-performance liquid chromatography and supercritical fluid chromatography (SFC) are the main chromatographic techniques used to separate enantiomers. Since chiral stationary phases are often extensively used once a method has been developed, columns will age and must be replaced after a certain period. However, no practical guidelines exist to determine when a column is deteriorated or to decide whether a transfer to another column (with the same chiral selector) is successful. In this study, a system suitability limit for resolution was defined, based on an intermediate (time-different) precision study in SFC on four immobilized polysaccharide-based columns that only differed in manufacturer or particle size. This system suitability limit could be used to decide on column deterioration or as a requirement to evaluate whether a separation transfer was successful. Some method adaptations may be necessary to obtain successful transfers. An approach was proposed, which helped the analyst to make successful transfers. Graphical abstract.

Tijdschrift: Anal. Bioanal. Chem.
ISSN: 1618-2642
Issue: 24
Volume: 412
Pagina's: 6221-6230
Jaar van publicatie:2020
Trefwoorden:Enantioseparations, Intermediate-precision study, Supercritical fluid chromatography, System suitability, Transfer
CSS-citation score:1
Toegankelijkheid:Open