表阿霉素卡拉胶寡糖-金纳米粒的制备和质量控制

Preparation and quality control of epirubicin carrageenan oligosaccharide Au nanoparticles

目的建立盐酸表阿霉素-卡拉胶寡糖-金纳米(EPI-CAO-AuNPs)中盐酸表阿霉素(EPI)的含量测定方法,并测定其包封率。方法采用ZORBAX-Extend-C_(18)色谱柱,以乙腈和水为流动相,对检测波长、流动相比例及pH、流速和柱温等因素进行优化。结果优化后最适色谱条件为:流动相为乙腈-水(30:70,体积比),含0.1%的三氟乙酸(TFA),柱温25℃,流速1.0mL/min,检测波长233nm。经测定,EPI-CAO-AuNPs中EPI的载药量为12.5%,包封率为94.3%。结论该测定方法操作简单,快速灵敏,重复性好,可在15min内完成测定,适用于EPI-CAO-AuNPs材料中EPI的含量检测。

Objective To establish a HPLC method for the content determination of epirubicin(EPI)in EPI-CAO-AuNPs.Methods ZORBAX-Extend-C18 column(4.6 mm×150 mm,5μm)was used for the determination of EPI with acetonitrile and water as the mobile phase.The chromatographic conditions including the detection wavelength,the ratio and pH of mobile phase,flow rate,and column temperature were optimized.Results The optimized chromatographic conditions were as follows:the volume ratio of acetonitrile-water was 30∶70 with 0.1% trifluoroacetic acid(TFA),the column temperature was at 25 ℃,the flow rate was 1.0 mL/min,the running time was 15 min,and the detection wavelength was 233 nm.The drug loading of EPI in EPI-CAO-AuNPs was 12.5%,and the encapsulation efficiency of that was 94.3%.Conclusion The established and optimized method was accurate,reliable and simple,which could be completed within 15 min.It is suitable for the content determination of EPI in EPICAO-AuNPs.