Objective  To establish a comprehensive quality evaluation method of Qirong Runchang oral liquid based on HPLC-QAMS quantitative control of multi-components and chemometrics analysis.

Methods  Verbascoside as the internal reference substance, the relative correction factor with other nine components was established. The contents of each component were calculated by external standard method and HPLC-QAMS method, and the test results were compared to verify the accuracy and feasibility of the established HPLC-QAMS method. The cluster analysis, principal component analysis and partial least squares-discriminant analysis of HPLC-QAMS test results were performed by chemometrics methods to establish the comprehensive quality evaluation method of Qirong Runchang oral liquid.

Results  There was a good linear relationship among the 10 quantitative control components in Qirong Runchang oral liquid (r>0.9990). The average recovery was 96.92% -100.11% (RSD<2.0%). There was no significant difference in the content between the two methods (P>0.05). The 12 batches of samples could be clustered into three categories by cluster analysis. The principal component analysis and partial least squares-discriminant analysis show that echinacoside, calycosin-7-O-β-D-glucopyranoside, atracylenolide Ⅲ, tubuloside A and verbascoside were the main markers affecting the difference of samples from different batches of Qirong Runchang oral liquid.

Conclusion  The comprehensive quality evaluation method of HPLC-QAMS quantitative control of multi-components combined with chemometrics is accurate, repeatability and stability, which can be used for the quality control of Qirong Runchang oral liquid.

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