摘要
目的建立水飞蓟素胶囊中水飞蓟素异构体的含量测定方法方法采用HPLC法,C18色谱柱(125mm×4.0mm,5μm);流动相为混合溶剂A[85%磷酸-甲醇-水(5∶35∶65)]和混合溶剂B[85%磷酸-甲醇-水(5∶50∶50)]梯度洗脱;流速:0.8mL/min;检测波长为288nm。结果水飞蓟宾在0.5088~2.5440μg范围内呈良好线性关系;加样回收率为99.5%,RSD=2.2%。结论该方法采用水飞蓟宾为对照品,在同一流动相条件下能够同时测定6种水飞蓟素异构体的含量,可用于水飞蓟素胶囊的质量控制。
Objective To establish a method for the determination of 6 isomers of silibin in silymarin Capsules. Method The RP - HPLC method was applied. Separation and determination of silibinin was performed on a ClS column( 125 mm × 4.0 mm) with the flow rate of 0.8 mL/min, temperature at 25 ℃ and detection wavelength at 288 nm. The mixed solvent of A (85 % phosphoric acid : methnol : water = 5 : 35 : 65) and B (85 % phosphoric acid : methnol : water = 5 : 50 : 50) served as the mobile phase (gradient elution). Results A good linearity of silibinin was in the rang of 0. 508 8 2. 544 0 μg( r = 0.999 8). The average recovery was 99.5 % and RSD was 2.2 % ( n = 5). Conclusion With silibinin as as the control, this method is simple and accurate and can be used for the determination of six isomers of silibin and can be used for quality control of Silymarin Capsules.
出处
《中药新药与临床药理》
CAS
CSCD
2006年第3期200-202,共3页
Traditional Chinese Drug Research and Clinical Pharmacology