Establishment of the HPLC Fingerprint of Qinghuo Zhimai Tablets and Determination of Three Constituents / 中国药师

ABSTRACT

Objective:To establish the HPLC fingerprint of Qinghuo Zhimai tablets and determine the contents of geniposide,andrographolide and dehydroandrographolide.Methods:The analysis was performed on a CAPCELL PAK C18 column (250 mm×4.6 mm,5 μm) with acetonitrile and water as the mobile phase with gradient elution at the flow rate of 1.0 ml·min-1.The detection wavelength was 225 nm,and the column temperature was 40℃.Totally 13 batches of Qinghuo Zhimai tablets from different manufacturers were analyzed to establish the fingerprint of Qinghuo Zhimai tablets.Results:There were 14 common peaks calibrated,and the HPLC fingerprint common pattern was established for the HPLC fingerprint of Qinghuo Zhimai tablets.Using the method of reference substance attribution,3 compounds were determined as geniposide,andrographolide and dehydroandrographolide.The similarity of 9 batches in the 13 batches of Qinghuo Zhimai tablets was higher than 0.9.The content determination of geniposide,andrographolide and dehydroandrographolide showed good linearity (r>0.999 8,n=6),the average recovery was 96.90%,97.55% and 97.07% and RSDs were 1.61%,1.45% and 1.47%(n=9),respectively.Conclusion:The method is simple and accurate with good repeatability,which can be used for the identification and evaluation of Qinghuo Zhimai tablets,and provides important scientific basis for the quality control of Qinghuo Zhimai tablets.