摘要
目的:研究色谱条件对药品制剂中淫羊藿苷含量测定结果的影响。方法:HPLC,采用C18色谱柱;分别以甲醇-水(54.5∶45.5)、甲醇-水-冰醋酸(54∶46∶0.5)和乙腈-水(25.5∶74.5)为流动相;检测波长为270nm。结果:以甲醇-水(54.5∶45.5)、甲醇-水-冰醋酸(54∶46∶0.5)为流动相时,淫羊藿苷色谱峰和淫羊藿定C色谱峰完全重叠,测得的含量比实际含量高。结论:应对相关国家药品标准进行修订,新建检测方法时,应做好方法学的验证。
Objective:To study The influences of liquid chromatography conditions on the determination of the content of icariin. Method: The HPLC was carried out on C18 column with methanol-water (54. 5: 45.5 ), methanol-water-acetic acid (54: 46 : 0. 5 ) or acetonitrile-water(25.5: 74. 5)as a mobile phase respectively. The detective wavelength was 270nm. Results: The peak response for icariin and epimedin C were superimposed completely when methanol-water(-acetic acid) were used as mobile phase, and the determined content of icariin was high compared with the actual content. Conclusion: It is necessary to revise the national standards of the related preparations.
出处
《中国药品标准》
CAS
2008年第1期43-46,共4页
Drug Standards of China