药品中残留溶剂的控制理念及测定方法的应用

Progress in the control concepts and determination methods of residual solvents in pharmaceuticals

目的:介绍各国不同药典在药品残留溶剂测定中的控制理念并探讨方法的应用。方法:以头孢孟多酯钠的残留溶剂检测为例,探讨了2015版《中华人民共和国药典》如何解决残留溶剂检测中的不确定性难题,建立适合待测样品残留溶剂的检测方法。结果:应用《中华人民共和国药典》2015版通则0861残留溶剂测定法,对不同生产厂家的头孢孟多酯钠的残留溶剂进行了全面准确的测定。结论:不同药典在残留溶剂测定中的设计和控制理念并不尽相同,《中华人民共和国药典》2015版通则中的双柱定性方法可以快速、准确地鉴别出药品中未知的残留溶剂。

Objective： To introduce the residual solvents determination methods in different pharmacopoeias and their applications. Methods： Determination of the residual solvents in cefamandole nafate was taken as an example to indicate how to establish the correct method using the residual solvents determination methods in general chapter 0861 of Chinese pharmacopoeia 2015 edition. Results： The residual solvents in cefamandole nafate from different manufactures were determined accurately using the methods in general chapter 0861 of Chinese pharmacopoeia 2015 edition. Conclusion： The control concepts and determination methods of residual solvents in pharmaceuticals are different in different pharmacopoeias. The residual solvents determination methods in general chapter 0861 of Chinese pharmacopoeia 2015 can be used to screening and confirm the unknown peaks using two opposite polar columns system.