基于UPLC MS/MS对盐酸表阿霉素中14-溴-4'-表柔红霉素的质量控制  

Quality Control of 4'-epi-14-bromo Daunorubicin in Epirubicin Hydrochloride Based on UPLC MS/MS

作　　者：周雪飞 和燕玲 雒文军 李春燕 段光玉 卢静静 丁安平 吴春艳 张辉 邵伍军 Zhou Xuefei;He Yanling;Luo Wenjun;Li Chunyan;Duan Guangyu;Lu Jingjing;Ding Anping;Wu Chunyan;Zhang Hui;Shao Wujun(Zhejiang Hisun Pharmaceutical Co.,Ltd.Taizhou,Zhejiang 318000,China;Taizhou Volational College of Science&Technology,Taizhou,Zhejiang 318000,China)

机构地区：[1]浙江海正药业股份有限公司,浙江台州318000 [2]台州科技职业学院,浙江台州318000

出　　处：《化工与医药工程》2023年第2期19-22,共4页Chemical and Pharmaceutical Engineering

基　　金：台州市科学技术局(21nya10);台州市科技计划项目(21nya24)。

摘　　要：建立超高效液相色谱-三重四级杆质谱(UPLC MS/MS)对盐酸表阿霉素中14-溴-4'-表柔红霉素质量控制的方法。采用Waters ACQUITY UPLC^(■)BEH C_(18)色谱柱进行分离,以0.1%甲酸水溶液为流动相A,乙腈为流动相B,梯度洗脱,质谱检测器,流速为0.3 mL/min。经验证14-溴-4'-表柔红霉素的线性范围为0.5474~10.9484 ng/mL,相关系数r=0.9999,方法检出限浓度为0.1642 ng/mL,定量限浓度为0.5474 ng/mL,样品加标回收率在99.0%~101.3%。可用于快速、简便、灵敏、准确地测定盐酸表阿霉素中14-溴-4'-表柔红霉素的含量。A quality control method for determination of 4'-epi-14-bromo daunorubicin in epirubicin hydrochloride by ultra-high performance liquid chromatography-tandem mass spectrometry(UPLC-MS/MS)was developed.The method was performed on a Waters ACQUITY UPLC^(■)BEH C_(18) column with the mobile phase consisting of 0.1%formic acid(phase A)and Acetonitrile(phase B)by gradient elution.The detector was mass spectrum.The flow rate was 0.3 mL/min.After verification,the linear range of 4'-Epi-14-bromo daunorubicin was 0.5474-109484 ng/mL with the correlation coefficients 0.9999.The limit of detection was 0.1642 ng/mL,and the limit of quantification was 0.5474 ng/mL.The recovery were 99.0%-101.3%.The method is rapid,simple,sensitive and accurate for the quantitative determination of 4'-epi-14-bromo daunorubicin in epirubicin hydrochloride.

关 键 词：盐酸表阿霉素 14-溴-4'-表柔红霉素 超高效液相色谱-三重四级杆质谱 

分 类 号：R927.1[医药卫生—药学]