Development and Validation of a High-Performance Thin-Layer Chromatographic Fingerprint Method for the Evaluation of QiYi Capsules with the Reference of Myotonin

摘要

The newly developed high-performance thin-layer chromatography (HPTLC) method allowed for the differentiation of QiYi capsules from 10 batches due to their characteristic fingerprints, proving to be a well-suited method for characterization and assignment of Traditional Chinese Medicine (TCM) preparation. The method was validated for repeatability, intra-precision, and inter-precision. The result was acceptable, with the reference of myotonin, because relative standard deviation (% RSD) was 3.9% in reproducibility test and less than 3.44% in inter- or intra-plate precisions. HPTLC fingerprinting of the extracts showed several peaks with different R_F values. Eleven peaks were selected as the common peaks to evaluate the similarities of 10 different samples with R_F values ranging from 0.10 to 0.87 according to fingerprint. The similarities of 10 batches of QiYi capsules were more than 0.940; it indicated that the different batches of QiYi capsules were stable and reliable in quality.