两种HPLC体系在左西孟旦注射液变色杂质研究中的应用

Dual-HPLC System in Studies of Colored Impurities in Levosimendan Injection

目的提高注射液质量标准及药物安全性。方法本文以左西孟旦注射液为模型药,探讨不同色谱体系复配使用并结合二级阵列管检测法在注射液变色杂质研究中的应用。结果左西孟旦注射液的有色杂质可以分为3类,其特征波长分别在370、450和483 nm附近。反相色谱中保留时间为31.2 min的杂质特征吸收为483 nm,可能是溶液变红的主要原因。结论采用两种色谱体系复配并结合二级阵列管检测法可用于注射液变色杂质的初步筛查和确定。

Objective To improve the quality specifications and safety of drugs. Methods The dual-HPLC system was combined with DAD detection to study colored impurities in levosimendan injection. Results The results showed that there were three kinds of impurities in the injection,and their characteristic wavelength was close to 370 nm,450 nm and 483 nm respectively. The impurity retained at 31. 2 min in the revere phase HPLC was considered the main source of red color because it possessed absorption at 483 nm. Conclusion This method can be used primarily for screening and determining colored impurities in injections.