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

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.