摘要
目的:建立 HPLC 法测定佛波双酯及其注射液的含量及有关物质。方法:色谱柱为 Kromasil KR100—5 C_(18)柱(250 mm×4.6 mm,5μm);流动相为:乙睛-甲醇-水(45:45:10);检测波长为:232 nm;流速为:1 mL·min^(-1)。结果:佛波双酯浓度在40.6～244.1μg·mL^(-1)范围内,线性关系良好(r=0.9999),低、中、高3种浓度的方法回收率分别为100.7%,100.7%,100.8%,RSD(n=3)均小于2%,佛波双酯与其有关物质能够完全分离。最低检出限为1.8 ng。结论:方法简便、准确,灵敏,可用于佛波双酯及佛波双酯注射液的含量测定及有关物质检查。佛波双酯原料的包装贮藏选择试验结果表明,本品的包装贮藏条件应为严封,避光,冷藏保存。
Objective：An HPLC method for the testing of related substances in phorbol diesters and phorbol diesters Injection was established. Method：The column：Kromasil KR100 -5 C18 column（250 mm × 4.6 mm,5 μm）. The mobile phase ： acetonitrile - methanol - water （ 45 ： 45 ： 10 ）. The detective wavelength ：232 nm. The flow rate ： 1.0 mL·min^-l. Result：A linearity between peak area and phorbol diesters concentration was achieved in the range of 40. 6 -244.1μg· mL^-1 ,with r =0. 9999. The method recoveries were 100.7% ,100.7% ,100. 8% and RSD（ n = 3）for low, medium, high were less than 2%. The related substance could be separated completely from phorbol diesters. The lowest limit of detection was 1.8 ng. Conclusion：The method is simple, accurate and sensi- tive, and can be used for the determination of impurity in phorbol diesters and phorbol diesters injection. The results of the stability study of phorbol diesters verified that it should be preserved in tight containers,light - resistant,in a cold place.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2008年第8期1284-1287,共4页
Chinese Journal of Pharmaceutical Analysis
关键词
高效液相色谱
佛波双酯
注射液
有关物质
包装贮藏条件
HPLC
phorbol diesters
injection
related substances
conditions of package and storage
