摘要
目的:建立乌檀注射剂中间体指纹图谱。方法:AgilentExtendC18柱,流动相为纯水～5%乙腈(0～10min),5%乙腈～50%乙腈(10～60min),50%乙腈～纯水(60～70min)梯度洗脱,流速0.7mL·min-1,检测波长245nm。结果:精密度、稳定性、重复性试验中各共有峰相对保留时间和相对峰面积的RSD均<3%,10批样品间具有很高的相似度。结论:本方法可以作为乌檀注射剂中间体的质量控制方法。
Objective： To establish HPLC fingerprints of unfinished product of Nauclea injection. Method： A high performance liquid chromatography assay was developed with an Agilent-Extend C18 column, a gradient elution：water-5% acetonitrile （10min）,5% acetonitrile-10% acetonitrile （10-60min）, 50% acetonitrile-water （60-70min）, a 0.7 mL·min^-1 flow rate, at detection wavelength, 245nm within a 70 min total elution time. Result： The RSD of relative retention time and peak area of coexist peaks meet to method requirement during the investigation of precision, stability and repeatibity trials. All of the 10 batches of samples share a high similarity. Conclusion： This method can be used to control the quality of unfinished product of Nauclea injection.
出处
《中国中药杂志》
CAS
CSCD
北大核心
2005年第15期1156-1158,共3页
China Journal of Chinese Materia Medica
