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Adoption of Fritillariae thunbergii bulbus describing alternative quality control test

15 January 2021
Strasbourg, France

At its 168th session, the European Phamacopoeia (Ph. Eur.) Commission adopted Fritillariae thunbergii bulbus (2588), the first monograph to describe a test for minimum content of two markers (peimine and peiminine) by high-performance thin layer chromatography (HPTLC). The decision to allow semi-quantitative HPTLC analysis as an alternative quality control test for non-authorised TCMs was taken by the Commission at its 163rd session (March 2019). At this session, the results of the pilot study carried out by the TCM Working Party (WP) were presented and showed that semi-quantitative HPTLC led to the same pass/fail results as an LC-assay, and therefore that it was a suitable method for quality control. The test can be carried out by the analyst in the context of the identification by HPTLC, thus it represents a user-friendly alternative that give the same information as the classical LC assay.   

This approach will be used by the TCM WP for future elaboration of new monographs when deemed appropriate; it is limited to herbal drugs which do not have a marketing authorisation and to the determination of analytical markers.

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