黄芪多糖注射液中非法添加地塞米松磷酸钠的检查方法研究

Studies on Astragalus Polysaccharide Added Illegally in the InjectionOf Dexamethasone Sodium Phosphate Check Method

关键词:  地塞米松磷酸钠  峰纯度  光谱相似度  平均回收率  检出限

Key words:  Dexamethasone sodium phosphate  peak purity  spectral similarity  the average recovery rate  detection limit

摘要:

通过对黄芪多糖注射液中非法添加地塞米松磷酸钠的检查方法的专属性考察,黄芪多糖注射液对地塞米松磷酸钠的检查无干扰,峰纯度指示、光谱相似度能满足要求；拟定黄芪多糖注射液中地塞米松磷酸钠的检测限为0.1mg/ml,对应黄芪多糖注射液中含量0.01%；平均回收率为98.9%；对柱温、流动相比例、流动相pH值和色谱柱变化对分离度、峰纯度指示、光谱相似度进行考察,能满足要求,只是保留时间变化。

Abstract:

Illegally added in astragalus polysaccharides injection of dexamethasone sodium phosphate of specificity, checking method of astragalus polysaccharide injection did not interfere with inspection of dexamethasone sodium phosphate, peak purity instructions, spectral similarity can meet the requirements; To formulate astragalus polysaccharide injection of dexamethasone sodium phosphate detection limit of 0.1 mg/ml, corresponding to 0.01% content of astragalus polysaccharides injection; The average recovery rate is 98.9%; The proportion of column temperature, mobile phase, mobile phase pH value and the change of chromatographic column separation degree, peak purity instructions, spectral similarity can meet the requirements, just keep time change.