Determination of four potential genotoxic impurities in apixaban by LC-MS/MS method
MA Ling-yun
MENG Yu-xin
ZHAI Chen-fei
YANG Dong-sheng
FENG Yu-fei
NIU Jian-zhao
LIU Qian
Abstract：Objective:To establish an LC-MS/MS method for determining the contents of genotoxic impurities in the raw material,generic and reference formulations of apixaban tablets,and evaluate the safety of apixaban tablets on the market.Methods:The potential target genotoxic impurities in apixaban were screened out through Derek and Sarah database,and an LC-MS/MS method was established and utilized to determine the contents of target genotoxic impurities in the raw material,generic and reference formulations of apixaban tablets.Results:The potential target compounds of genetic toxic impurities in apixaban were PGI-1,PGI-2,PGI-3,PGI-4;the limit of the target genetic toxic impurities was calculated to be 75 μg·g-1,and experimental results showed that the detected contents of the four potential genetic toxic impurities in apixaban raw material drug and formulations were less than 2 μg·g-1.Conclusion:PGI-1,PGI-2,and PGI-4 were detected in the raw material drug and generic formulations of apixaban,and PGI-1 was detected in the reference apixaban tablets,but all of them were far below the genetic toxic impurity limit(75 μg·g-1),indicating that the genetic toxic risk of apixaban tablets on the current market is low.
Keywords：apixabangenotoxic impurityLC-MS/MS methodgeneric formulation
Publication Date：2026-02-28
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：8( 367-374 )