目的:建立HIV-1病毒感染因子Vif抑制药VEC-5脂质体中VEC-5含量及包封率的HPLC检测方法。方法:采用冻干重建法制备VEC-5脂质体,超速离心法分离游离药物与脂质体,HPLC法测定脂质体中VEC-5的含量及包封率。结果:VEC-5在20~100μg·ml-1范围内线性关系良好(r=0.999 0)。平均回收率为100.25%,RSD为0.93%(n=9)。检测三批VEC-5脂质体样品的含量分别为98.63%、100.43%、102.65%,均在标示量的90%~110%之间;包封率分别为94.89%、93.68%、94.56%,均在90%以上,符合药典关于脂质体制剂包封率大于80%的要求。结论:该方法准确、可靠,可用于VEC-5脂质体中VEC-5含量及包封率的测定。 OBJECTIVE: To establish an HPLC method for the determination of VEC-5 content and entrapment efficiency in VEC-5 liposomes, an HIV-1 viral infection Vif inhibitor. Methods: VEC-5 liposomes were prepared by freeze-drying reconstruction method. Free drug and liposomes were separated by ultracentrifugation method. The content and entrapment efficiency of VEC-5 in liposomes were determined by HPLC. Results: The linearity of VEC-5 in the range of 20 ~ 100μg · ml-1 was good (r = 0.999 0). The average recovery was 100.25% with a RSD of 0.93% (n = 9). The contents of the three batches of VEC-5 liposomes were 98.63%, 100.43% and 102.65% respectively, all of which ranged from 90% to 110% of the labeled amount. The entrapment efficiencies were 94.89%, 93.68% and 94.56% Are more than 90%, in line with the Pharmacopoeia liposome formulation encapsulation efficiency greater than 80% of the requirements. Conclusion: The method is accurate and reliable, and can be used for the determination of VEC-5 content and encapsulation efficiency in VEC-5 liposome.