关键词: 丹葛酚酮胶囊, 指纹图谱, 含量测定, HPLC

Abstract: To provide the scientific basis for the quality evaluation of Dangefentong Capsule,its HPLC fingerprints was established，and the contents of nine components were simultaneously determined.The analyses were performed on an Eclipse XDB-C₁₈ column (4.6 mm×250 mm,5 μm),and the mobile phase comprised of 0.05% formic acid (A) and acetonitrile (B) with the gradient elution at a flow rate of 1.0 mL/min.The detection wavelength was set at 280 nm;the column temperature was maintained at 30 ℃ and the injection volume was 10 μL.Twenty-eight common peaks were selected in the fingerprints of ten batches of samples,the similarities of which were more than 0.99.Sixteen components were identified by comparison with the reference substances.Nine major components,namely,3′-hydroxy puerarin,puerarin,3′-methoxy puerarin,puerarin celery glycoside,daidzin,salvianolic acid B,cryptotanshinone,tanshinone I and tanshinone Ⅱ_A were analyzed quantitatively.The linearity,precision,stability,repeatability,and recovery were all in line with quantitative requirements.The established method is simple,stable and reliable,and can be expected for the quality control of Dangefentong Capsules.

Key words: Dangefentong Capsule, fingerprints, quantitative determination, HPLC