论文部分内容阅读
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 injection quality standards and drug safety. Methods In this paper, levosimendan injection as a model drug to explore the use of different chromatographic systems combined with secondary array tube detection method in the application of discoloration impurities in injection. Results The levosimendan injection of colored impurities can be divided into three categories, the characteristic wavelength of 370,450 and 483 nm in the vicinity. The characteristic absorption of impurities at a retention time of 31.2 min in reversed phase chromatography at 483 nm may be the main reason for the reddening of the solution. Conclusion The two chromatographic systems combined with two-stage array tube detection method can be used for initial screening and determination of injection discoloration impurities.