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

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 RF values. Eleven peaks were selected as the common peaks to evaluate the similarities of 10 different samples with RF 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.