摘要
目的建立多烯磷脂酰胆碱胶囊中多烯磷脂酰胆碱含量及溶血磷脂酰胆碱的限量检查。方法丙二醇键合硅胶色谱柱(5μm,4.6×250mm,Hanbon),柱温:55℃,流动相:A为正己烷-异丙醇-冰醋酸-三乙胺(814:170:15:1.4),B为异丙醇-水-冰醋酸-三乙胺(844:140:15 :1.4),梯度洗脱,流速:1 ml·min^(-1),蒸发光散射检测器物化温度50℃,蒸发温度90℃,载气流速2.0 ml·min^(-1)。结果多烯磷脂酰胆碱在0.1~1mg·mL^(-1)范围内呈良好线性,r=0.9999;平均回收率为100.1%,RSD为1.7%;中间精密度RSD为1.4%;三批样品中多烯磷脂酰胆碱的标示量%分别为100.9%,99.84%,100.2%,溶血磷脂酰胆碱的含量占多烯磷脂酰胆碱表示量的3.9%,4.4%,3.9%。本样品中磷脂酰乙醇胺未检出。结论所建立的方法可准确的测定胶囊中多烯磷脂酰胆碱的含量及溶血磷脂酰胆碱的限量检查,可用于该制剂的质量控制。
OBJECTIVE To establish a method for the determination of polyene phosphatidylcholine capsules by HPLC. METHODS Colunm:Dior(5μm,4.6 ×250mm,Hanbon) ,55℃ ;mobile phase: A: N-hexane-IPA-glacialacetic-TEA(814: 170: 15: 1.4),B :IPA-water-glacialacetic-TEA(844: 140: 15: 1.4);flowrate: 1ml ·min^ -1; ELSD: NEB: 50℃, EVP: 90℃, RATE: 2.0 ml · min^-1. RESULTS Polyene phosphatidylcholine had good linear relationship between 0.1 · 1mg · mL^-1 ; RSD% of middle precision : 1.4% ; RSD% of recovery: 1.7%. CONCLUSION The method is convenient, reliability, good reproducibility, and can be used in the quality control of the preparation.
出处
《海峡药学》
2007年第5期29-31,共3页
Strait Pharmaceutical Journal
关键词
HPLC-ELSD
多烯磷脂酰胆碱
质量标准
HPLC
Polyene phosphatidylcholine
Lysophosphatidyl choline
Hosphatidyl - ethanolamine