Study on Fingerprint and Content of Sugar Components in Compound Kushen Injection

OBJECTIVE To establish the sugar fingerprint of Compound Kushen injection by HPLC-ELSD, and to determine the contents of fructose, terpinol, glucose and sucrose in Compound Kushen injection simultaneously.METHODS The chromatographic column was Prevail Carbohydrate ES(4.6 mm×250 mm, 5 μm). The mobile phase was acetonitrile-water with gradient elution. The flow rate was 1 mL·min^–1. The column temperature was 15 ℃. The ELSD drift tube temperature was 60 ℃. The atomization temperature was 60 ℃. The carrier gas(N₂) flow rate was 1.5 L·min^–1.RESULTS The sugar fingerprint of Compound Kushen injection was established, and 6 common peaks were distinguished. The similarity of 10 batches of samples were all >0.95. In the corresponding concentration range, 4 sugar components respectively showed the good linear relationships between the concentrations and the peak areas. The correlation coefficients were >0.999 6. The average recovery rates(n=9) were 104.85%, 103.40%, 105.34% and 104.71%, respectively. The RSDs were 2.55%, 2.98%, 1.65% and 2.58%, respectively.CONCLUSION The established method of fingerprint and multi-content determination method is simple with good repeatability, which can provide comprehensive reference for quality control of Compound Kushen injection.