中兽医医药杂志2025，Vol.44Issue(3)：80-83,4.DOI:10.13823/j.cnki.jtcvm.2025.031
HPLC-MS/MS法测定阿哌沙班中氨基物杂质
Determination of amino impurities in Apixaban by HPLC-MS/MS
摘要
Abstract
A HPLC-MS/MS(high-performance liquid chromatography-triple quadrupole mass spectrometry)method was established for the determination of amino impurity contents in Apixaban.The determination was performed on an Agilent Eclipse Plus C18 column with the mobile phase consisting of 0.1%acid formate(phase A)and acetonitrile(phase B)by gradient elution.The detector was mass spectrum.The flow rate was 0.4 mL/min.The results indicated that the amino impurity linear ranges were 1-20 ng/mL,with correlation coefficients(r)>0.999 0.The method limit of detection was 0.3 ng/mL and the quantification limit was 1.0 ng/mL.The spiked sample recoveries ranged 95.20%-104.40%with RSD<3.0%.The method is simple,sensitive and efficient for accurate determination of amino impurity contents in Apixaban.关键词
高效液相色谱-三重四极杆质谱/阿哌沙班/氨基物/杂质Key words
high performance liquid chromatography-triple quadrupole mass spectrometry(HPLC-MS/MS)/Apixaban/amino/impurities分类
农业科技引用本文复制引用
邱卫晓,丁安平,和燕玲,邵伍军,徐文昊,赵二强,管伶俐,李伟举..HPLC-MS/MS法测定阿哌沙班中氨基物杂质[J].中兽医医药杂志,2025,44(3):80-83,4.基金项目
台州市科学技术局(24gyb20,24nya17) （24gyb20,24nya17）
