高效液相蒸发光散射色谱法测定盐酸氨基葡萄糖片有关物质的研究

目的：建立盐酸氨基葡萄糖片有关物质检查的高效液相色谱分析方法。方法：采用Applied BiosystemsBrownleeTM（SPHERI-5 CYANO,220 mm×4.6 mm,5μm）色谱柱;流动相为乙腈-0.1%三氟乙酸水溶液（70∶30）;流速：0.4 ml/min;柱温：30℃;检测器为Alltech ELSD 2000ES蒸发光散射检测器（仪器参数：漂移管温度85℃,气体流速2.0L/min,Gain=1,Impactor=off）。结果：盐酸氨基葡萄糖主峰有较高响应值的同时,与杂质峰分离度良好,辅料无干扰。供试品溶液在0.05～0.4 mg/ml范围内,精密度及线性关系良好（R2=0.999 4）。结论：测定方法简便、准确、灵敏度高,方法可靠,可用于盐酸氨基葡萄糖片的有关物质检测。

Study on determination of related substances in glucosamine hydrochloride tablets by HPLC-ELSD

Objective: To establish an HPLC-ELSD method for determination of related substances in Glucosamine Hydrochloride Tablets.Methods: The separation was performed with a Applied Biosystems BrownleeTM column(SPHERI-5 CYANO,4.6 mm×220 mm,5 μm)at 30 ℃;The mobile phase was a mixture of acetonitrile(70%) and 0.1% trifluoroacetic acid solution(30%) at a flow-rate of 0.4 ml/min.An Alltech ELSD 2000ES detector of drift tube temperature at 85 ℃ was used and the gas flow was 2.0 L/min.The value of the Gain was 1 and the Impactor was turned off.Results: In this chromatogram system,the peak of glucosamine hydrochloride had higher response value.And the resolution between the peaks of glucosamine hydrochloride and impurity was good.Furthermore,the preparation supplementary material had no interference.In the range of 0.05 ~0.4 mg/ml,the precision and linear was perfect.Conclusion: This method is simple,accurate,sensitive and applicable for determination of related substances in glucosamine hydrochloride tablets.