OBJECTIVE

2

To establish a method for qualitative and quantitative analysis of Shangkeling spray，which can be a certain foundation for the overall quality evaluation of Shangkeling spray.

METHODS

2

Eleven batches of Shangkeling spray were determined by high performance liquid chromatography （HPLC）.The separation was perfor

med on Ultimate

®

XB-C

18

column with mobile phase consisted of acetonitrile-0.1% phosphoric acid （gradient elution） at the flow rate of 1.0 mL/min. The detection wavelength was set at 210 nm，and column temperature was 35 ℃.

Similarity Evaluation Software of Chromatographic Fingerprint of Traditional Chinese Medicine

（2012 edition） was used for the establishment of HPLC characteristic chromatogram and similarity analysis； the chromatographic peaks were identified by comparing with the chromatogram of the reference substance. The contents of matrine，oxymatrine，scopoletin and isoazinopyridine were determined by HPLC.

RESULTS

2

Totally 18 common characteristic peaks were demarcated for 11 batches of samples，4 of them were identified，i.e. peak 2 （matrine），peak 3 （oxymatrine），peak 6 （scopoletin），peak 7 （isoazinopyridine）. The similarity between the characteristic chromatogram of 11 batches of samples and the control characteristic chromatogram R was ≥0.990. The results of content determination methodology conformed to the relevant requirements. The contents of matrine，oxymatrine，scopoletin and isoazinopyridine in 11 batches of Shangkeling spray were 14.48-44.86，32.53-69.76，11.28-20.96 and 10.36-22.49 μg/mL，respectively.

CONCLUSIONS

2

HPLC characteristic chroma- togram and quantitative analysis method of 4 indicator components are successfully established in this study，which can be used to evaluate the quality of this preparation.