HPLC法测定长春碱亲水基修饰阳离子脂质体中主药含量及脂质体的包封率

目的:建立测定长春碱亲水基修饰阳离子脂质体中主药含量及脂质体的包封率的方法。方法:采用高效液相色谱法。色谱柱为迪马C18柱,流动相为乙腈-甲醇-二乙胺(13∶53∶34,V/V/V),检测波长为281 nm,流速为1.0 ml/min,柱温为30℃,进样量为10μl。采用葡聚糖凝胶柱分离法分离长春碱亲水基修饰阳离子脂质体游离药物以测定包封率。结果:长春碱检测质量浓度在0.02～0.30 mg/ml范围内与峰面积积分值呈良好的线性关系(r=0.999 6);精密度、稳定性、重复性试验的RSD≤1.88%;低、中、高浓度的平均加样回收率为99.82%,RSD=0.15%(n=9);所测脂质体的平均包封率为86.40%。结论:该方法准确可靠、简单快速、重复性好,可用于脂质体的药物含量及包封率的测定。

Determination of the Content of Main Component and Entrapment Efficiency of Vinblastine Hydrophilic Group Modified Cationic Liposome by HPLC

OBJECTIVE： To establish a method for the content determination of main component and the entrapment efficiency of Vinblastine hydrophilic group modified cationic liposomes. METHODS： HPLC method was adopted. The determination was carfled out on C18 column with mobile phase consisted of acetonitrile-methanol-diethylamine （13 ： 53：34, V/V/V） at the flow rate of 1.0 ml/min. The column temperature was at 30℃ and the sample size was 10 μl. The free drug of Vinblastine hydrophilic group modified cationic liposomes was separated by sephadex column so as to detect the encapsulation rate. RESULTS： The linear range of vinblastine were 0.02-0.30 mg/ml （r-=-0.999 6） with an average recovery of 99.82% （RSD=0.15%, n=9）. RSDs of precision, stability, and repeatability tests were all ≤ 1.88%. The average encapsulation rate was 86.40%. CONCLUSIONS： The method is accurate, reliable, simple, rapid and reproducible, and it can be used for the determination of the content and encapsulation rate of liposomes.