摘要
目的对茶碱缓释胶囊含量测定标准提出修改建议。方法比较两种色谱条件的系统适用性参数及含量测定结果,并对茶碱对照品的使用方法进行探讨。结果原标准方法和改进方法色谱峰的保留时间分别为23.2 min和6.2 min;峰宽分别为1.21 min和0.62 min;峰高分别为124.1 mV和328.6 mV,两种方法的系统适用性参数及含量测定结果差异无统计学意义(P<0.01),但原方法容易导致仪器出故障,分析周期过长,分析成本大大增加;拟改进法则能避免上述情况的出现。另外,原方法中茶碱对照品使用规定不合理,拟改进方法则符合对照品的使用常规,并可进一步降低成本。结论可用拟改进方法代替原标准方法。
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 rain and 0.62 rain;Peak height respectively were 124.1 mV and 328.6 inV. 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 fail- ure 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.
出处
《武警医学》
CAS
2013年第7期572-574,共3页
Medical Journal of the Chinese People's Armed Police Force
关键词
茶碱
茶碱缓释胶囊
茶碱对照品
含量测定
theophylline
theophylline sustained - release capsules
theophylline reference substance
content determination
