Objective:To establish the fingerprint of the intermediate of Dalitong Granules; To control its quality with QAMS method.Methods:Gradient elution was performed by HPLC on Wondasil C18 superb column (4.6 mm × 250 mm, 5 μm). The mobile phase was 0.02% acetonitrile - acetic acid aqueous solution, gradient elution. The detection wavelength was 325 nm and the injection volume was 10 μl. The column temperature was 30 ℃, and the flow rate was 1.0 ml/min. Chemical recognition patterns were combined for analysis, and QAMS method was used for content determination.Results:Through methodological investigation, the fingerprint of Dalitong Granule Extract had good repeatability. The 10 batches of Dalitong Granule Extract could be divided into 3 categories through clustering analysis and principal component analysis. The relative correction factors of four components in Dalitong Granule Extract were established. Compared with external standard method, the established QAMS method has higher reliability.Conclusion:The established fingerprint and QAMS method can be used for the quality control of Dalitong Granule Extract.

HPLC method was used for the determination of related substances in (E)-4-[2-(4-chlorophenoxy)-2-methylpanoyloxy]-3-methoxyphenyl acrylic acid. The separation was achieved by Ultimate XB-C18 column (4.6 mm×150 mm,5 μm) with mobile phase composed of methanol-1% acetic acid water (70∶30) at a wavelength of 275 nm. The results showed that (E)-4-[2-(4-chlorophenoxy)-2-methylpanoyloxy]-3-methoxyphenyl acrylic acid with various intermediates and compulsory destruction of degradation products were well separated. The impurity limit in three batches of API was less than 0.1% and the main impurity C was isolated and identified. Within the range from 0.20 to 59.96 μg/mL, the mass concentration of impurity C has good linear relationship with the peak area (r=0.999 9). The control method of related substances for (E)-4-[2-(4-chlorophenoxy)-2-methylpanoyloxy]-3-methoxyphenyl acrylic acid was established by impurity reference method and self-high and low concentration comparison. Methodological validation can be used for the detection of related substances of (E)-4-[2-(4-chlorophenoxy)-2-methylpanoyloxy]-3-methoxyphenyl acrylic acid.