盐酸苯达莫司汀原料药含量测定方法的比较  

Comparative Study on Determination Method of Bendamustine Hydrochloride

作　　者：沈红梅 SHEN Hong-mei(Kelun Pharmaceutical Research Institute Co.,Ltd.,Sichuan Chengdu 611130,China)

机构地区：[1]四川科伦药物研究院有限公司,四川成都611130

出　　处：《广州化工》2021年第3期55-57,共3页GuangZhou Chemical Industry

摘　　要：为了比较盐酸苯达莫司汀原料药含量测定的不同方法,建立更加简单、快速的含量测定方法,分别采用HPLC法和非水滴定法对盐酸苯达莫司汀原料药的含量测定进行研究。结果表明,HPLC测定盐酸苯达莫司汀线性范围为10.284~41.1μg/mL,相关系数r=0.99992,最低检测浓度为1.34×10-9 g/mL,精密度(RSD=0.15%)良好;非水滴定法测定具有快速、精密度高、重现性好等优点。两种方法均可作为盐酸苯达莫司汀原料药含量的测定,无显著性差异。In order to compare different methods for the content determination of bendamustine hydrochloride,and to establish a more simple and rapid method,HPLC and non-aqueous titration were used to determine the content of bendamustine hydrochloride.The results showed the calibration curve of bendamustine hydrochloride was linear within 10.284~41.1μg/mL,related coefficient was 0.99992,the least detecting concentration was 1.34×10-9 g/mL,and the method was of precision(RSD=0.15%).The non-aqueous titration method has the advantages of fast speed,high precision and good reproducibility.The two methods can be used to determine the content of bendamustine hydrochloride.

关 键 词：盐酸苯达莫司汀 含量测定 高效液相色谱法 非水滴定法 

分 类 号：R917[医药卫生—药物分析学]