HPLC测定盐酸苯达莫司汀纯度和降解破坏

Determination on the Purity and Degradation of Bendamostine Hydrochloride by HPLC

目的:通过HPLC测定盐酸苯达莫司汀纯度及其降解破坏的实验情况,从而进一步验证该方法的可行性;方法:色谱柱:ZORBAX BONUS-RP(4.6×150 mm,5 um);流动相:A:0.1%TFA水溶液,B:0.1%TFA乙腈溶液;流速:1.0 mL/min,检测波长254 nm,柱温30℃;最后,使用设定好的梯度方法进行洗脱。结果:盐酸苯达莫司汀在强酸、强碱、氧化、高温以及其溶液样品在强光条件下都出现不同程度的降解,只有其固体样品在强光照射下相对稳定。结论:在选定的色谱条件下,该方法能够较好地对盐酸苯达莫司汀和其它降解产物进行分离,确定产物的纯度,并了解其降解破坏的情况,为盐酸苯达莫司汀的存放和使用条件提供一定的参考依据。

Objective:To determine the purity and degradation of bendamostine hydrochloride by HPLC,so as to further verify the feasibility.Method:B:Acetonitrile solution containing 0.1%TFA;flow rate:1.0ml/min,detection wavelength:254nm,column temperature:30℃;finally,elution is carried out by the set gradient method.Results:Bendamostine was degraded in different degrees in strong acid,strong base,oxidation,high temperature and under strong light,only its solid sample was relatively stable under strong light.Conclusion:Under the selected chromatographic conditions,this method can be used to separate bendamostine hydrochloride and other degradation products,determine the purity of the products,and understand the degradation and damage of bendamostine,so as to provide some reference for the storage and use conditions of bendamostine.