反相高效液相色谱法分析两性霉素B及其脂质体  

RP-HPLC determination of amphotericin B and its liposome

作　　者：朱会琴[1] 胡昌勤[1] 赵霞[1] 

机构地区：[1]中国药品生物制品检定所

出　　处：《药物分析杂志》2006年第7期949-952,共4页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立反相高效液相色谱法测定两性霉素 B 及其脂质体含量与相关物质。方法:采用 YMC C_(18)(150 mm×4.6 mm,5 μm)色谱柱,流动相为甲醇-乙腈-2.5 mmol·L^(-1)乙二胺四乙酸二钠溶液(41:18:41),柱温30℃,检测波长407 nm,流速为1.0 mL·min^(-1)。结果:两性霉素 B 及其杂质可完全分离;进样20μL时,线性浓度范围为5～120μg·mL^(-1)(含量测定),0.2～10μg·mL^(-1)(相关物质检查);最低检测限(LOD)为29.3 ng·mL^(-1)(SIN=3),最低定量限(LOQ)为98.9 ng·mL^(-1)(S/N=10);日内精密度(RSD)为2.2%(n=6),日间精密度(RSD)为3.4%(n=8);脂质体测定的平均回收率为99.34%,RSD为0.79%(n=7)。结论:该方法简便、快速、专属,可用于对两性霉素 B 及其脂质体的含量和相关物质的控制。Objective： To establish an RP - HPLC method for determination of the assay and related substance of amphotericin B and liposomal amphotericin B. Method：A YMC C18 column（ 150 mm × 4. 6 mm,5 μm） was used with a mobile phase of methanol -acetonitrile -2. 5 mmol L^-1 ethylenecliamine tetra -acetic acid clisodium salt （41： 18：41）,the column temperature was 30 ℃ and the UV detected was set at 407 mn, the flow rate was 1.0 mL·min^-1 Results：The linear range of assay for determination and related substance was 5 - 120 μg · mL^-1 and 0. 2 - 10 μg · mL^-1 respectively, the LOD was about 29.3 ng · mL^-1 （ S/N = 3 ） and the LOQ about 98. 9 ng· mL ^-1 （S/N = 10）. T he precision （RSD） was 2. 2% （ u = 6 ） for intra - day and 3. 4% （ u = 8 ） for inter - day. The average recovery of the liposome determination was about 99. 34% （ RSD =0. 79% ,u = 7 ）. Conclusion： The method is simple, fast and selective. It is suitable for control of the quality of amphotericin B and its preparations.

关 键 词：反相高效液相色谱法 两性霉素B 脂质体 

分 类 号：R917[医药卫生—药物分析学]