高原康胶囊质量标准研究

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。

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.

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