Determination of trace genotoxic impurity in Eltrombopag Olamine by LC-MS method
SUN Yingji
CHEN Qite
LI Tiejun
GUO Zhiqiang
LI Peipei
XU Yuwen
Abstract：Objective To establish an LC-MS analytical method for the rapid determination of trace genotoxic impurityⅡ-10,2-(3,4-dimethylphenyl)-4-(hydroxyimino)-5-methyl-2,4-dihydro-3H-pyrazole-3-ketone in Eltrombopag Olamine.Methods Impurity Ⅱ-10 was separated by gradient elution at the chromatographic conditions below:column:Waters ACQUITY UPLC BEH C18(2.1 mm×50 mm,1.7 μm),mobile phase A:0.1％formic acid aqueous solution,mobile phase B:0.1％formic acid methanol solution,flow rate:0.3 mL·min-1,column temperature:20 ℃.Quantitative determination of impurity Ⅱ-10 was performed by multiple reaction monitoring(MRM).Results The analytical method was found to be of good specificity and shown good linear correlation between 7.8～117.8 ng·mL-1.The test demonstrated that the LOD and LOQ of impurity Ⅱ-10 were 2.4 ng·mL-1 and 7.8 ng·mL-1,respectively,and the recovery was 90％～104.1％(RSD:5.5％).Conclusion The method was simple and rapid,of good specificity and accuracy.
Keywords：Eltrombopag OlamineLC-MS methodMRMGenotoxic impurity
Publication Date：2025-09-30
Online Publishing Date：2025-10-30(First online date of this platform, not the publication date of the document)
Pages：5( 864-868 )