Some problems and Suggestions in content determination of Theophylline sustained-release capsules
CHEN Haidong1,QIN Zhigao2,and Pang Yuna3.
1. Deparment of Pharmacy,Guangxi Zhuang Autonomous Region Hospital of Chinese People’s Armed Police Forces,Nanning 53000,China;
2.Nanning Institute for Food and Drug Control,Nanning 530001,China;
3. Deparment of Pharmacy,Poeople＇s Hospital of Bobai City.Guangxi 537600,China
Abstract：Objective To suggest and propose amendments for content determination of theophylline sustained-release capsules standard.Methods The system suitability parameters of two chromatographic condition and the content determination results were compared, and use method of theophylline reference substance was explored.Results The original standardmethod and the improved methods of chromatographic peak of retention timerespectively were 23.2 min and 6.2 min;Peak width respectively were 1.21 min and 0.62 min;Peak height respectively were 124.1 mV and 328.6 mV. There was no significant difference (P<0.01) between system suitability parameters of the two methods and the results of content determination, but the former method was easy to cause failure of analysis instrument, long cycle, and cost of analysis greatly increased. Intended method of improve went avoided the arising of the above situation. In addition, the original stipulated method of theophylline reference substance use is unreasonable, the method for improving the use of reference substance routine is suggested, and can further reduce the cost.Conclusion A method for improve can be used to replace the original standard method.
2013, Vol. 24 
