Determination of polysorbate 80 and EDTA in Fosaprepitant Dimeglumine for Injection by HPLC -ELSD
WANG Gang
LIU Jianping
SHEN Yanli
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.
Keywords：Fosaprepitant Dimeglumine for InjectionHPLC -ELSDPolysorbate 80EDTADetermination
Publication Date：2016-01-01
Online Publishing Date：2025-08-15(First online date of this platform, not the publication date of the document)
Pages：3( 151-153 )