摘要
目的建立HPLC-电雾式检测器(Charged Aerosol Detection,CAD)检测脂质体磷脂含量及降解产物的方法。方法选用几种类脂材料制备成空白脂质体注射剂及冻干粉针剂,利用HPLC-CAD测定脂质体磷脂膜中各种类脂的含量,采用反相C8色谱柱,流动相为甲醇-水,梯度洗脱,流速1 mL.min-1。结果4种类脂材料的平均回收率分别为99.2%,98.7%,99.5%,99.1%;RSD分别为1.1%,1.5%,0.8%,1.3%。结论实验充分证明了HPLC-电雾式检测器联合应用,可以快速、高效、准确地检测脂质体中的磷脂含量及杂质。
OBJECTIVE To develop a HPLC-CAD method for the determination of DSPE-PEG, phosphatidylcholine ( DPPC), DSPG,lysophosphatidylcholine (MPPC) in phospholipid bilayer of blank liposomes for injection. METHODS A separation was performed on a C8 column with the mobile phase of methanol-water gradient elution at the flow rate of 1 mL·min^-1. RESULTS The average recoveries of DSPE-PEG,DSPG,MPPC and DPPC were 99. 2% ,98. 7% ,99.5% and 99. 1% and with RSDs of 1.1% ,1.5%, 0. 8% and 1.3% respectively. CONCLUSION HPLC-CAD,a new method for phospholipids analysis,provides high sensitivity and reproducibility.
出处
《中国药学杂志》
CAS
CSCD
北大核心
2007年第23期1794-1796,共3页
Chinese Pharmaceutical Journal