HPLC同时测定葛兰心宁软胶囊中5种异黄酮成分的含量

Simultaneous Determination of Five Isoflavone Components of Gelanxinning Soft Capsules by HPLC

目的建立HPLC法同时测定葛兰心宁软胶囊中异黄酮类成分3’-羟基葛根素、葛根素、3’-甲氧基葛根素、大豆苷、大豆苷元的含量。方法超声提取法制备样品,采用Prevail C18色谱柱(250 mm×4.6 mm,5μm);流动相:乙腈(A)-0.5%甲酸溶液(B),梯度洗脱;流速:1.0 m L·min^(-1);检测波长:250 nm;柱温:25℃。结果 3’-羟基葛根素、葛根素、3’-甲氧基葛根素、大豆苷、大豆苷元分别在0.006~0.030,0.040~0.200,0.012~0.060,0.001 2~0.006 0,0.001 2~0.006 0 mg·m L^(-1)范围内线性关系良好;平均加样回收率为97.16%~98.50%,RSD均小于1.9%。结论该方法简便、准确,可用于葛兰心宁软胶囊中3’-羟基葛根素、葛根素、3’-甲氧基葛根素、大豆苷、大豆苷元的含量测定,为葛兰心宁软胶囊的质量控制提供参考。

Objective To establish a method for simultaneously determination of 3 ＇-hydroxy puerarin,puerarin,3＇-methoxy puerarin, daidzin and daidzein in Gelanxinning soft capsule. Methods Samples were prepared byultrasonic extraction. HPLC analysis was carried out using a Prevail C18 column（5 μm,250 mm × 4.6 mm i.d.）,with acetonitrile（A）-0.5% formic acid solution（B） as mobile phase by gradient elution,and a flow rate of 1.0 m L·min^（-1）,a detection wavelength at 250 nm and a column temperature of 25 ℃. Results Good linear relationshipswere found for 3 ＇-hydroxy puerarin, puerarin, 3＇-methoxy puerarin, daidzin, and daidzein in the range of0.006-0.030 mg·m L-1,0.040 0-0.200 0 mg·m L-1,0.012 0-0.060 0 mg·m L^（-1）,0.001 2-0.006 0 mg·m L^（-1）,0.001 2-0.006 0 mg·m L^（-1）,respectively. The average recovery rates ranged from 97.2% to 98.5%,and all RSDs were lessthan 1.9%. Conclusion The established method is simple and accurate, and can be used for simultaneousdetermination of 3 ＇-hydroxy puerarin,puerarin,3＇-methoxy puerarin,daidzin and daidzein in Gelanxinning softcapsule. The study also provides reference for the quality control of Gelanxinning soft capsule.