A Useful Strategy to Evaluate the Quality Consistency of Traditional Chinese Medicines Based on Liquid Chromatography and Chemometrics.

ABSTRACT

Evaluation of the batch consistency of traditional Chinese medicines (TCMs) is essential for the promotion of the development and quality control of TCMs. The aim of the present work was to develop a useful strategy via liquid chromatography and chemometrics to evaluate the batch consistency of TCM preparations. Xin-Ke-Shu (XKS) tablet was chosen as a model for this method development. Four types of chromatographic fingerprint approaches were compared by using similarity analysis based on cosine of angel or correlation coefficient. Differences in the fingerprints of 71 batches of XKS tablet were illustrated by hierarchical cluster analysis. Then, Mahalanobis distance was employed for estimating the probability level (P < 0.05) of the differences mentioned above. Additionally, t-test was applied to find out the chromatographic peaks which had significant differences. For XKS tablet, the maximum wavelength fingerprint had the largest range and dispersion degree of similarity as compared with the other three ones. There were two clear clusters in all the batches of samples. And we clearly arrived at the conclusion that higher similarity does not exactly indicate small Mahalanobis distance, while lower similarity indicated larger Mahalanobis distance. Finally, a useful strategy was proposed for evaluation of the batch consistency of XKS tablet.