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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 for the determination of albuterol in albuterol sulfate drug substance. Methods The method of determination of impurity salbutamol in salbutamol sulfate inhalation aerosol of Pharmacopoeia of the People’s Republic of China 2015 and the method of determination of impurity salbutamol contained in the drug substance contained in “European Pharmacopoeia” 9.0 Compare, select the appropriate method and methodological verification. Results Both HPLC methods were able to detect the content of salbutamol in APIs, but the method in Pharmacopoeia of the People’s Republic of China 2015 was better. Conclusion The method of HPLC contained in Pharmacopoeia of the People’s Republic of China 2015 is preferable as the detection method of salbutamol in salbutamol sulphate drug substance.