An alternative and simplified approach to identification and test for minimum content of TCM herbal drugs.

Following a decision of the European Pharmacopoeia (Ph. Eur.) Commission, the Traditional Chinese Medicines (TCM) Working Party started a pilot phase to examine the suitability of a high-performance thin-layer chromatography (HPTLC) minimum content test as an alternative to the classical assay in TCM monographs. This approach was evaluated with two TCM herbal drugs: Fritillaria thunbergii bulbs (FTB) and Corydalis rhizome (CYR). Firstly, the existing HPTLC methods were optimised for both drugs. The new methods were applied to the evaluation of multiple samples, and acceptance criteria for the identification, following Ph. Eur. chapter 2.8.25. High-performance thin-layer chromatography of herbal drugs and herbal drug preparations, were set. The HPTLC test for minimum content of markers was then developed and validated. In this test, the intensity of the marker zone in the fingerprint of the sample is compared to the corresponding zone in the reference solution, which has a concentration giving an intensity equivalent to the acceptance criterion. This test gives a pass or fail result rather than a content and can be performed visually (on the images) or by software (using peak profiles from images; PPI). Reproducibility of the HPTLC methods was evaluated in a collaborative trial including six laboratories. In summary, results for FTB from five laboratories were in agreement. The remaining laboratory did not pass the identification of the samples. For CYR, all laboratories presented the same results for identification. In the test for minimum content, one borderline sample passed in four laboratories and failed in two. All laboratories reached similar conclusions for the other seven samples. The HPTLC methods proposed offer a simplified approach to evaluating identity and minimum content of TCM drugs in a single analysis.