摘要
目的:应用RP-HPLC建立了勒马回注射剂的指纹图谱,并对相似度计算软件应用过程中存在的问题进行了探讨。方法:用Beckman C18(4.6 mm×250 mm,5μm)甲醇-0.5%冰醋酸溶液恒流洗脱,流速1 mL·min～1,检测波长254 nm。结果:建立了注射剂HPLC指纹图谱共有模式,并对不同批注射剂进行了相似度比较。结论:勒马回注射剂各成分得到了很好的分离,可作为该注射剂的指纹图谱。
Objective: The fingerprint chromatography of Lemahui Injection was established by using reversed -phase high perfomance liquid chromatography. And we discuss some questions when we used the software of similar degree. Methods:Beckman C18 colume was used, with mixtures of 0. 5% acetic acid - water and methanol as mobile phase. The flow rate was 1 mL · min-1. The wavelength of detection was 254 nm. Results; After the mutual mode of HPLC fingerprint was set up, comparsion of similar degree to the injection of different batch has been carried on. Conclusion; According to the selected chromatographic conditions, a good fingerprint of the injection has been described. The method is simple, accurate with good reproducibility. It may be practical value for the quality control of
sample for Lemahui iniection.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2004年第5期519-522,共4页
Chinese Journal of Pharmaceutical Analysis
基金
国家药典委员会项目 药典业发(2002)第196号
