丹葛酚酮胶囊HPLC指纹图谱及9种有效成分的含量测定

Establishment of HPLC fingerprint of Dangefentong Capsule and determination of nine components

建立丹葛酚酮胶囊的HPLC指纹图谱,并同时测定其中9种有效成分的含量,为其质量评价提供依据。采用Eclipse XDB-C 18色谱柱(4.6 mm×250 mm,5μm),以0.05%甲酸-乙腈为流动相梯度洗脱,流速1.0 mL/min,检测波长280 nm,柱温30℃,进样量10μL,建立了丹葛酚酮胶囊的HPLC指纹图谱。10批丹葛酚酮胶囊指纹图谱中有28个共有峰,相似度均大于0.99,经与对照品比对确认了16个成分,对葛根素、3′-羟基葛根素、3′-甲氧基葛根素、葛根素芹菜糖苷、大豆苷、丹酚酸B、隐丹参酮、丹参酮Ⅰ、丹参酮ⅡA 9种主要成分进行了定量分析,线性、精密度、稳定性、重复性和加样回收率均符合定量要求,所建立的方法简便、稳定、可靠,指纹图谱结合多指标成分的含量可有效控制产品的质量。

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-C 18 column(4.6 mm×250 mm,5μm),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 10μL.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.