药学研究2016，Vol.35Issue(3)：151-153,3.DOI:10.13506/j.cnki.jpr.2016.03.009
HPLC －ELSD 法测定注射用福沙匹坦二甲葡胺中聚山梨酯80和 EDTA 的含量
Determination of polysorbate 80 and EDTA in Fosaprepitant Dimeglumine for Injection by HPLC -ELSD
王刚 1刘建平 1沈艳丽1
作者信息
- 1. 鲁南制药集团股份有限公司，山东 临沂 276006
- 折叠
摘要
Abstract
Objective To establish an HPLC -ELSD for the determination of polysorbate 80 and EDTA in Fosaprepi-tant Dimeglumine for Injection.Methods The chromatographic analysis was carried out on a TSK -GEL G2500PWXL (7.8 mm ×300 mm,7 μm).The mobile phase consisted of 0.02 mol·L -1 ammonium acetate -acetonitrile(90∶10)with the flow rate of 0.6 mL·min -1 .The column temperature was 30 ℃.The drift tube temperature of ELSD was 110 ℃ and gas flow rate of nitrogen was 2.6 L · min -1 .Results The linear range of polysorbate 80 was 418.80 ~1 256.40μg·mL -1 (r =0.999 3),and the average recovery was 98.55%,with the RSD of 0.99%.The linear range of EDTA was 100.56 ~301.68 μg·mL -1 (r =0.999 9),and the average recovery was 100.13%,with the RSD of 0.52%.Conclusion The method was rapid,accurate and reproducible.It can be used for the quality control of polysorbate 80 and EDTA in Fosaprepitant Dimeglumine for Injection.关键词
注射用福沙匹坦二甲葡胺/高效液相 -蒸发光散射检测器色谱/聚山梨酯 80/乙二胺四乙酸/测定Key words
Fosaprepitant Dimeglumine for Injection/HPLC -ELSD/Polysorbate 80/EDTA/Determination分类
药学引用本文复制引用
王刚,刘建平,沈艳丽..HPLC －ELSD 法测定注射用福沙匹坦二甲葡胺中聚山梨酯80和 EDTA 的含量[J].药学研究,2016,35(3):151-153,3.
