摘要
目的 建立扎那米韦反相高效液相色谱( RP-HPLC)分析方法,测定其固体脂质纳米粒的包封率.方法 色谱柱为Inertsil ODS-3 C18柱(250 mm×4.6 mm,5μm),流动相为乙腈-水(10∶90),流速0.6 ml/min,检测波长235 nm,进样量20μl.采用复乳化溶剂挥发法制备扎那米韦固体脂质纳米粒,扫描透射电镜观察纳米粒形态,激光粒度分析仪考察纳米粒的粒径分布和表面电位,并测定其包封率及载药量.结果 在该色谱条件下扎那米韦与辅料及溶剂峰分离良好,扎那米韦在0.5～100.0μg/ml浓度线性范围内与峰面积呈良好的线性关系(r=0.9999,n=8),日内精密度试验的相对标准偏差(RSD)为0.59％ ～2.03％ (n=3),日间精密度试验的RSD为1.06％～1.88％ (n=3),平均回收率为100.11％ (n=3).所制得固体脂质纳米粒形态比较圆整,粒径为(183.9±5.7)nm,Zeta电位为(-53.0±1.6)mV,包封率和载药量分别为(36.1±2.8)％和(0.32±0.03)％.结论 该RP-HPLC分析方法简便、易行,可用于扎那米韦固体脂质纳米粒的包封率测定.
Abstract
Objective To establish a reverse phase high performance liquid chromatography (RP-' HPLC ) method and to determine the encapsulation efficiency of zanamivir-loaded solid lipid nanoparticles (SLNs). Methods RP-HPLC analysis was performed on an Inertsil ODS-3 Cl8(250 ×4.6 mm,5 μm) column with mobile phase of acetonitrile-water(10: 90). The flow rate was 0.6 ml/min. The wavelength of UV detector was set at 235 nm and the injection volume was 20 μl. Zanamivir-loaded SLNs was prepared by a double emulsion solvent evaporation method. Transmission electron microscropy (TEM) was conducted to investigate the morphology of SLNs. The mean diameter and zeta potential of SLNs were measured by photon correlation spectroscopy. The entrapment efficiency and drug loading amount of SLNs were detected by RP-HPLC. Results It had a good linear relation in the range of 0. 5 ~ 100.0 μg/ml (r = 0.999 9). The intra-day precision ( RSD) was 0. 59% ~ 2. 03% ( n = 3 ). The inter-day precision (RSD) was 1.06% -1.88% (n=3). The average recovery rate was 100. 11% (n = 3). The SLNs were sphere like with the average size of (183. 9 ±5. 7)nm and zeta potential of(-53.0±1.6) mV. The encapsulation efficiency and drug loading amount of SLNs were (36.1 ±2.8)% and (0.32 ± 0.03) % , respectively. Conclusion The developed RP-HPLC method is simple, accurate and reliable for determination of entrapment efficiency of zanamivir-loaded SLNs.
基金项目
2010年度苏州大学大学生创新性实验计划项目(5731513010)
苏州大学人才引进项目(Q4132901)
NETL
NSTL
维普
万方数据