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The European Pharmacopoeia recognizes image semi quantitative HPTLC technology to assist in the quality control of traditional Chinese medicine
Date: 2025-08-04Read: 0
Abstract: At the 168th meeting of the European Pharmacopoeia Committee, a monograph on quality control testing of Fritillariae thunbergii bulbus (number 2588) was approved. High performance thin-layer chromatography (HPTLC) was used to determine the two biomarkers, berberine A (0.06%) and berberine B (0.02%).
Advantages of HPTLC image quantitative quality control:
Synchronized with identification, one image for multiple purposes
Direct image quantification without the need for a thin-layer scanner
Easy to operate, good reproducibility of standardized parameters
The monograph passed this time is of great significance. As early as the 163rd meeting in March 2019, the committee decided to allow semi quantitative HPTLC analysis as an alternative quality control test for unauthorized traditional Chinese medicine. This decision is based on the pilot study conducted by the Traditional Chinese Medicine Working Group, which showed that the pass/fail results of semi quantitative HPTLC and liquid chromatography were consistent and suitable as quality control methods.
In the future, the Traditional Chinese Medicine Working Group will consider using this method when developing new monographs, but only for the determination of herbs and analytical markers without marketing authorization.