顶空气相色谱法测定卡博替尼中的溶剂残留  

Determination of solvent residues in Cabozantinib by headspace gas chromatography

作　　者：宋小飞 王红芳 王潞娜 柴青叶 张辉 SONG Xiao-fei;WANG Hong-fang;WANG Lu-na;CHAI Qing-ye;ZHANG Hui(Shanxi Zhendong Pharmaceutical Co.,Ltd.,Changzhi 047100,China)

机构地区：[1]山西振东制药股份有限公司,山西长治047100

出　　处：《化学工程师》2024年第8期35-38,21,共5页Chemical Engineer

摘　　要：本研究建立了卡博替尼原料药经气相色谱-火焰离子化检测器检测13种有机溶剂残留的分析方法。13种有机残留溶剂在各自质量浓度范围内与对应峰面积的线性关系良好,相关系数均大于0.995;回收率在90.4%~107.8%%之间,9次测定结果的相对标准偏差为1.44%~5.04%。该方法操作简单,准确度高,灵敏度好,可用于检测卡博替尼原料药中有机溶剂残留。An analytical method for the detection of 13 organic solvent residues Cabozatinib API by gas chromatography-flame ionization detector was established in this study.The linear relationship between 13 kinds of residual organic solvents and corresponding peak area is good,and the correlation coefficient is greater than 0.995.The recovery rate was in the range of 90.4%~107.8%,and the relative standard deviation of nine test was in the range of 1.44%~5.04%.The method has the advantages of simple operation,high accuracy and good sensitivity,and can be used to detect organic solvent residues in Cabozatinib API.

关 键 词：气相色谱法 卡博替尼 有机溶剂残留 质量控制 

分 类 号：R917[医药卫生—药物分析学]