UPLC-MS/MS法同时测定双丹胶囊、双丹颗粒、双丹口服液中7种成分

目的建立UPLC-MS/MS法同时测定双丹胶囊、双丹颗粒、双丹口服液(丹参、牡丹皮)中丹参酮ⅡA、丹参素、丹酚酸B、丹皮酚、迷迭香酸、没食子酸、原儿茶酸的含量。方法3种制剂50%乙腈提取液的分析采用XBridge BEH C18色谱柱(2.1 mm×100 mm,2.5μm);流动相乙腈-水(含0.1%甲酸),梯度洗脱;体积流量0.5 mL/min。采用电喷雾离子源,正负离子全扫描模式。结果7种成分在各自范围内线性关系良好(r>0.9990),平均加样回收率96.7%~102.6%,RSD 1.1%~4.5%。结论该方法简便、快速、灵敏,可用于双丹胶囊、双丹颗粒、双丹口服液的质量控制。

Simultaneous determination of seven constituents in Shuangdan Capsules,Shuangdan Granules and Shuangdan Oral Liquid by UPLC-MS/MS

AIM To establish a UPLC-MS/MS method for the simultaneous content determination of tanshinoneⅡA,salvianic acid A,salvianolic acid B,paeonol,rosmarinic acid,gallic acid and protocatechuic acid in Shuangdan Capsules,Shuangdan Granules and Shuangdan Oral Liquid(Salviae miltiorrhizae Radix et Rhizoma,Moutan Cortex).METHODS The analysis of 50%acetonitrile extracts of three preparations were performed on a XBridge BEH C18 column(2.1 mm×100 mm,2.5μm),with the mobile phase comprising of acetonitrile-water(containing 0.1%formic acid)flowing at 0.5 mL/min in a gradient elution manner.Eletrospray ionization source was adopted in positive/negative ion full scanning mode.RESULTS Seven constituents showed good linear relationships within their own ranges(r>0.9990),whose average recoveries were 96.7%-102.6%with the RSDs of 1.1%-4.5%.CONCLUSION This simple,rapid and sensitive method can be used for the quality control of Shuangdan Capsules,Shuangdan Granules and Shuangdan Oral Liquid.