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目的建立齐多夫定硬脂酸酯脂质体中药物含量测定的方法。方法采用Hypersil BDSC18柱(4.6mm×200mm,5μm),流动相为甲醇-水(95∶5,V∶V),流速1.0mL·min-1,检测波长265nm,柱温为室温。结果在此色谱条件下齐多夫定硬脂酸酯与辅料及溶剂峰分离度符合要求,在5.060～30.36mg·L-1范围内线性关系良好(r=0.9999,n=5),此方法回收率在101.3%～102.0%,日内及日间RSD均小于2.2%(n=5),脂质体的包封率为88%～92%。结论此方法准确可靠、简单快速,可用于齐多夫定硬脂酸酯脂质体的药物含量及包封率的测定。
Objective To establish a method for the determination of the drug content of zidovudine stearate liposomes. Methods The Hypersil BDSC18 column (4.6 mm × 200 mm, 5 μm) was used. The mobile phase was methanol-water (95: 5, V:V) and the flow rate was 1.0 mL · min-1. Results The chromatographic conditions zidovudine stearate and excipients and solvent peak resolution meet the requirements in the range of 5.060 ~ 30.36mg · L-1 good linear relationship (r = 0.9999, n = 5), this method The recoveries ranged from 101.3% to 102.0%. The intra-day and inter-day RSDs were less than 2.2% (n = 5). The encapsulation efficiency of liposomes ranged from 88% to 92%. Conclusion This method is accurate, reliable, simple and rapid and can be used for the determination of drug content and encapsulation efficiency of zidovudine stearate liposomes.