摘要
目的:建立HPLC法测定生脉注射液中聚山梨酯80含量,并与分光光度法测定结果进行比较。方法:采用TSKgeL G2000SWXL(300 mm×7.8 mm,5μm)色谱柱;流动相为0.02 mol·L^(-1)乙酸铵-乙腈(90∶10);流速为0.6 ml·min^(-1);柱温为30℃;ELSD检测条件:漂移管温度110℃,氮气流速2.3 L·min^(-1)。结果:聚山梨酯80在4.046~20.230μg范围内呈良好的线性关系(r=0.997 6),平均回收率为98.9%,RSD为2.7%(n=9)。HPLC法与分光光度法测定结果的差异无统计学意义(P>0.05)。结论:HPLC法操作简便,重复性好,结果准确可靠,可用于聚山梨酯80含量控制。
Objective： To establish the determination method for polysorbate 80 in Shengmai injections by HPLC. Method： HPLC was adopted with a TSKgeL G2000SWXL（300 mm x7.8 mm, 5 μm） column. The mobile phase consisted of 0.02 mol L-1 ammoni- um acetate-acetonitrile（90： 10） with the flow rate of 0.6 ml · min-l and the column temperature was 30℃. The temperature of drift tube was ll0. The flow rate of N2 was 2.3 L · min-1. Result： The linear range of polysorbate gl） was 4.046-20.230 p,g（ r = 0. 997 6）, and the average recovery was 98.9% （ RSD = 2.7%, n = 9 ）. Conclusion： The method is simple and accurate, and can be used in the determination of polysorbate 80.
出处
《中国药师》
CAS
2013年第9期1377-1379,共3页
China Pharmacist
