RP-HPLC法测定半乳糖化肝靶向葫芦素B脂质体中药物含量

目的建立半乳糖化肝靶向葫芦素B脂质体中药物含量测定的方法,对制剂进行有效的质量控制。方法采用RP-HPLC法。色谱柱为Diamonsil C18柱(200 mm×4.6 mm,5μm),流动相为乙腈-水(体积比50∶50),流速1 mL.min-1,检测波长233 nm,柱温35℃。结果在本色谱条件下,半乳糖化肝靶向脂质体辅料对葫芦素B的测定无干扰,葫芦素B质量浓度在1.0~20 mg.L-1内与峰面积呈良好的线性关系(r=0.9999,n=5),葫芦素B平均回收率为100.6%,RSD为1.0%(n=9)。结论本法准确、可靠、简便、快速,可用于半乳糖化肝靶向葫芦素B脂质体中药物含量的质量控制。

Content determination of cucurbitacin B in galacto-sylated hepatocyte-targeting liposomes by RP-HPLC

Abstract: Objective To establish an RP-HPLC method for the determination of cucurbitacin B in galactosylated hepatocyte-targeting liposomes. Methods The separation was performed by HPLC with a Diamonsil C18 reversed-phase column (200 mm×4.6 mm, 5 µm) at 35 ℃ with a mobile phase consisting of acetonitrile-water (V:V=50:50). The flow rate was 1.0 mL·min-1 and the effluent was monitored photometrically at 233 nm for the determination of cucurbitacin B. Results Cucurbitacin B had a good linear relation over the range of 1.0-20 mg·L-1 (r=0.999 9, n=5). The average recovery of cucurbitacin B was 100.6 % and RSD was 1.0 % (n=9). Conclusions An accurate and simple method is established for the determination of cucurbitacin B in galactosylated hepatocyte-targeting liposomes.