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高原康胶囊质量标准研究
Quality standard of Gaoyuankang capsules
【摘要】 目的:建立高原康胶囊的质量标准。方法:采用高效液相色谱法测定高原康胶囊中地西泮、地塞米松磷酸钠、氨茶碱3组分含量,并对高原康胶囊的有关物质、溶出度进行检测。结果:该方法下胶囊中3组分具有很好的分离效果,线性关系良好(r均大于0.99),回收率测定结果均在99.6%~101.0%之间,精密度试验(地塞米松磷酸钠、地西泮、氨茶碱峰面积的RSD分别为0.35%、1.27%、0.15%)和重复性试验(地塞米松磷酸钠、地西泮、氨茶碱含量的RSD分别为0.54%、0.57%、0.23%)结果较佳。结论:本方法操作简便,准确,重复性好,可用于高原康胶囊的质量控制。
【Abstract】 Objective:To establish the quality standard of Gaoyuankang capsules.Method:HPLC was adopted to determine diazepam,dexamethasone sodium phosphate and aminophylline in Gaoyuankang capsules.Then,related substances and dissolution were studied.Results:The three constituents were well separated,all the recoveries were between 99.6% and 101.0%,the results of precision(peak area RSDs of dexamethasone sodium phosphate,diazepam,aminophylline were 0.35%,1.27% and 0.15%,respectively)and repeatability(content RSDs of dexamethasone sodium phosphate,diazepam,aminophylline were 0.54%,0.57% and 0.23%,respectively)were good.Conclusion:The method is simple,accurate with good reproducibility and can be used for quality control of Gaoyuankang capsules.
【Key words】 diazepam; dexamethasone sodium phosphate; aminophylline; content determination; related substances; quality control; HPLC;
- 【文献出处】 药物分析杂志 ,Chinese Journal of Pharmaceutical Analysis , 编辑部邮箱 ,2013年03期
- 【分类号】R82
- 【被引频次】2
- 【下载频次】170