高效液相色谱法测定洛莫司汀脂质体药物含量及包封率

HPLC Determination of Content and Entrapment Efficiency of Lomustine in Liposome

目的:建立测定洛莫司汀脂质体药物含量及包封率的RP-HPLC法。方法:采用Diamonsil^(TM)C_(18)柱(250mm×4.6mm,5μm);流动相:乙腈-0.05mol·L^(-1)磷酸二氢铵溶液-三乙胺(60∶40∶0.2,磷酸调pH为3.5);柱温:室温;流速:1.0mL·min^(-1);紫外检测波长:232nm。采用Sephadex G-50分离洛莫司汀脂质体中的游离药物。结果:在本色谱条件下洛莫司汀与辅料及溶剂峰分离良好,洛莫司汀在4.0-48.0μ·mL^(-1)范围内线性关系良好(r=1.0,n=5),回收率在98.0%-101.0%之间,日内RSD及日间RSD均小于2%(n=5)。结论:说明该方法准确可靠、简单快速,可用于洛莫司汀脂质体含量及包封率的测定。

Objective: To establish a RP-HPLC method for content and entrapment efficiency determination of Lomustine liposomes. Method:The separation was performed with a Diamonsil~■ C_(18) Column(250 mm 4. 6 mm,5 μm),and the mobile phase was acetonitrile-0. 05mol·L^(-1) ammonium dihydrogen phosphate solution-triethylamine(60:40: 0. 2,pH was adjusted to 3. 5 using phosphoric acid),flow rate was 1. 0 mL·min^(-1) and lomustine was detected at 232 nm,a room column temperature. Result: Lomustine had a good linear relation in the range of 4.0-48.0μg·mL^(-1)(r= 1.0,n=5),the intra-day RSD and inter-day RSD were less than 2% (n=5), the average recovery was between 98. 0%-101. 0%. Conclusion: This method is simple, accurate, sensitive and applicable for determination of content and entrapment efficiency of lomustine liposomes.