RP-HPLC测定注射用卡莫司汀脂质体的药物含量及包封率

RP-HPLC determination of content and entrapment efficiency of carmustine liposome for injection

目的:建立卡莫司汀脂质体药物含量及包封率的测定方法。方法:采用 Shimadzu C_(18)色谱柱(250 mm×4.6mm,5μm);流动相:甲醇-0.05 mol·L^(-1)磷酸二氢铵溶液(60:40,用10%磷酸溶液调节 pH 值为4.0),柱温:室温,流速:1.0 mL·min^(-1);紫外检测波长:230 nm。采用 Sephadex G-50分离卡莫司汀脂质体中的游离药物。结果:在本色谱条件下,卡莫司汀与辅料峰分离良好,溶剂不干扰测定,卡莫司汀在20.0～80.0μg·mL^(-1)范围内线性关系良好(r=0.9999),回收率在98.0%～101.0%之间,日间 RSD 及日内 RSD 均小于2.0%(n=5)。结论:该方法准确可靠,简单快速,可用于卡莫司汀脂质体药物含量及包封率的测定。

Objective：To establish a method for content and entrapment efficiency determination of cannustine lipo-some for injection. Method：The separation was performed with a Shimadzu C18 column （250 mm×4.6 mm,5 μm） , and the mobile phase was methanol-0.05 mol·L^-1ammonium dihydrogen phosphate solution （60： 40, pH was adjusted to 4.0 using 10% phosphoric acid solution） ,flow rate was 1.0 mL·min^-1and carmustine was detected at 230 nm, a room column temperature. Result： Carmustine had a good linear relation in the range of 20.0-80.0 μg·mL^-1 ,the intra-day RSD and inter-day RSD were less than 2.0% （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 carmustine liposome for injection.