Study on HPLC Fingerprint Combined with Chemometric to Analyze the Quality Differences of Xinnaojian Capsule(Tablet) in Different Enterprises

OBJECTIVE To establish an approach for quality evaluation of Xinnaojian capsule(tablet) and to compare the quality differences of Xinnaojian capsules(tablets) in different enterprises. METHODS Transformed the characteristic chromatogram of Xinnaojian capsule(2020 edition of Chinese Pharmacopoeia) into fingerprint method, and method evaluation was performed. By comparing with control drugs, the characteristic peaks were investigated. Then twenty-one batches of samples from 3 enterprises were determined and their fingerprints were compared by analysis of similarities. Then hierarchical cluster analysis and principal component analysis were applied in pattern recognition. RESULTS The fingerprints of Xinnaojian capsule(tablet) from three enterprises differed. The results of hierarchical cluster analysis and principal component analysis were consistent, which indicated that the fingerprints of the samples from the same manufacturer could cluster to their own group. The characteristic peaks of 10(epigallocatechin-3-gallate), 13(gallocatechin gallate), 16(epicatechin-3-gallate) showed the greatest impact on the fingerprints. The content of epigallocatechin-3-gallate in samples of enterprise H was low, which was only 60.08% of that in samples of enterprise N, while the content of gallocatechin gallate was higher in samples of enterprise H. The content of gallocatechin gallate in samples of enterprise S was lower, which was 42.47% of that in samples of enterprise N, while the content of epicatechin-3-gallate was higher in samples of enterprise S. In addition, the proportion of the main components in the samples of different enterprises were not the same. CONCLUSION HPLC fingerprinting with aid of chemometric analysis is simple, objective and easy to realize digitalization and can reflect the differences of chemical component and proportion between samples more intuitively.