中国药业2025，Vol.34Issue(10)：87-91,5.DOI:10.3969/j.issn.1006-4931.2025.10.018
苹果酸卡博替尼4种潜在基因毒性杂质含量测定
Content Determination of Four Potential Genotoxic Impurities in Cabozantinib Malate
摘要
Abstract
Objective To establish high performance liquid chromatography method for simultaneous determination of four potential genotoxic impurities in cabozantinib malate.Methods The chromatography column was Agilent ZORBAX SB-C18 column(250 mm×4.6 mm,5 µm),the mobile phase was 10 mmol/L dipotassium hydrogen phosphate solution(pH adjusted to 5.5 with phosphoric acid)-acetonitrile(gradient elution),the flow rate was 1.0 mL/min,the detection wavelength was 220 nm,the column temperature was 30℃,and the injection volume was 20 µL.Results The linear ranges of impurities A,B,C,and D were in the range of 0.103 0-10.300 0 µg/mL,0.100 5-10.050 0 µg/mL,0.104 0-10.400 0 µg/mL,0.100 4-10.040 0 µg/mL,respectively(r=1.000 0).The limits of quantification were 0.103 0,0.100 5,0.104 0,0.100 4 µg/mL,respectively.The limit of detection were 0.030 9,0.030 2,0.031 2,0.030 1 µg/mL,respectively.The RSDs of precision,stability and repeatability tests were all lower than 4.0%.The average recovery rates of the above four components were 97.50%,94.32%,100.05%,97.83%,with RSDs of 1.68%,3.64%,2.65%,1.57%(n=9)respectively.Conclusion The established method is easy,accurate and reliable,which can be used to control the quality of four potential genotoxic impurities in cabozantinib malate.关键词
苹果酸卡博替尼/基因毒性杂质/含量测定Key words
cabozantinib malate/genotoxic impurities/content determination分类
医药卫生引用本文复制引用
王潞娜,王红芳,游蓉丽,宋小飞,宋荧荧,李昆..苹果酸卡博替尼4种潜在基因毒性杂质含量测定[J].中国药业,2025,34(10):87-91,5.基金项目
山西省科学技术厅中试基地项目[2022D100014070417320341163987]. （）
