盐酸氨基葡萄糖胶囊有关物质测定方法研究

Determination of related substances in Glucosamine Hydrochloride Capsules

目的：建立测定盐酸氨基葡萄糖胶囊有关物质的高效液相色谱方法。方法采用C18柱（250mm×4．6mm，5μm）；以庚烷磺酸钠溶液（0．5g庚烷磺酸钠溶解在水中，加0．5mL磷酸，再加0．224g氢氧化钾，加水稀释至1000mL，摇匀）-乙腈（1000∶50）为流动相；流速1．0mL·min-1；检测波长：195nm；柱温：室温。结果盐酸氨基葡萄糖胶囊对酸稳定，对碱、高温、强氧化破坏不稳定，其线性范围为6．32～31．60μg·mL-1。结论此方法简便，准确，快速，专属性强，可用于该制剂的有关物质检查。

Objective To establish an HPLC method for the determination of related substances in Glucosamine Hydrochloride Cap-sules .Methods The separation was performed on a C18 （250 mm × 4 .6 mm ,5 μm） column at room temperature .The mobile phase was a mixture of sodium 1-heptanesulfonate solution and acetonitrile at a flow-rate of 1 .0 mL · min-1 .The detection wave-length was at 195 nm .Results The Glucosamine Hydrochloride Capsules was stable with acid destruction ,but unstable with alka-li ,high temperature and strong oxidative destruction .The linear range was 6 .32-31 .60 μg · mL -1 .Conclusion This method is simple ,accurate ,and rapid with high specificity .It is applicable for the determination of related substances in Glucosamine Hydro-chloride Capsules .