摘要
目的建立阿魏酸钠胶囊剂含量及有关物质的RP-HPLC测定方法。方法采用Agilent ZORBAX SB-C18色谱柱,以水-甲醇-冰醋酸(64∶35∶1)为流动相,流速为0.9mL·min-1,检测波长为322nm。结果阿魏酸钠胶囊中有关物质能完全分离,在15.6～67.5μg.mL-1范围内线性关系良好(r=0.9999);平均回收率为99.9%(n=9,RSD=0.5%)。结论本法专属性强,准确度高,能满足制剂质量控制的要求。
Objective To establish the determination method of Sodium Ferulate Capsules and its related substances. Methods Agilent ZORBAX SB-C18 was used, and the mobile phase was water, methanol and glacial acetic acid （64 ： 35 ： 1） with the flow rate of 0. 9mL·min^-1. The detective wavelength was 322nm. Results Good separation for related substances in Sodium Ferulate Capsules was achieved The good calibration range was 15.6-67. 5μg·mL^-1 （r=0. 9999）, the average recovery was 99. 9% （n=9, RSD=0. 5%）. Conclusions The method is specific, accurate and suitable for the quality control of the drug.
出处
《中国药事》
CAS
2009年第5期464-466,共3页
Chinese Pharmaceutical Affairs
