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.
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The authors would like to thank Ana Ocaña for performing a part of the experiments during her Erasmus stay. The authors are grateful to Phenomenex and YMC for providing columns.
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Declerck, S., Vander Heyden, Y. & Mangelings, D. Defining a system suitability limit to decide on column deterioration and to facilitate column transfers in chiral supercritical fluid chromatography. Anal Bioanal Chem 412, 6221–6230 (2020). https://doi.org/10.1007/s00216-019-02173-7
- Supercritical fluid chromatography
- Intermediate-precision study
- System suitability