摘要
目的建立硫酸沙丁胺醇原料药中沙丁胺酮的HPLC检测方法。方法采用《中华人民共和国药典》2015版中硫酸沙丁胺醇吸入气雾剂中杂质沙丁胺酮的测定方法和《欧洲药典》9.0中收载的原料药中杂质沙丁胺酮收载的测定方法进行比较,选取适用的方法并进行方法学验证。结果两种HPLC方法均能检测原料药中沙丁胺酮含量,但《中华人民共和国药典》2015版中的方法分离效果更佳。结论优选《中华人民共和国药典》2015版收载的HPLC方法作为硫酸沙丁胺醇原料药中沙丁胺酮的检测方法。
Objective： To establish HPLC method to determine salbutamol ketone in salbutamol sulfate raw material. Methods： the determination method of salbutamol ketone impurity in salbutamol sulfate aerosol in Ch.p 2015 and the determination method of salbutamol ketone impurity in APIs in EP9.0 were compared, and a suitable method was used carry out methodological validation. Results： Both HPLC methods can detect salbutamol ketone in APIs.The separation effect of method in Ch.p2015 is better than that in EP9.0.Conclusion： The HPLC method in Ch.p2015 should be used as the detection method for salbutamol ketone in APIs.
出处
《辽宁化工》
CAS
2017年第10期1032-1035,共4页
Liaoning Chemical Industry
