HPLC测定盐酸氨基葡萄糖有关物质与含量

发布时间：2018-07-09 15:14

  本文选题：盐酸氨基葡萄糖 + N-乙酰氨基葡萄糖　； 参考：《中国药学杂志》2017年04期

【摘要】：目的建立HPLC测定不同厂家盐酸氨基葡萄糖制剂的含量及有关物质,考查了3种剂型8个厂家的产品质量差异。方法采用Phenomenex Luna NH2色谱柱(4.6 mm×250 mm,5μm),以磷酸盐缓冲液(称取7.0 g磷酸氢二钾溶解在适量水中,加0.5 m L氨水,加水稀释至2 000 m L,用磷酸调节p H值至7.5)-乙腈(25∶75)为流动相,流速为1.5 m L·min~(-1),柱温为30℃,检测波长为195 nm。结果盐酸氨基葡萄糖系统适用性试验符合要求,主峰与相邻杂质峰之间的分离度大于1.5。盐酸氨基葡萄糖在0.156 64~15.664 mg·m L~(-1)内线性关系良好(r=0.999 9)。平均回收率为101.14%,RSD为1.20%(n=9)。结论本方法可同时测定盐酸氨基葡萄糖的有关物质和含量测定,为该产品的质量控制提供参考。
[Abstract]:Objective to establish a HPLC method for the determination of glucosamine hydrochloride and its related substances in different factories, and to examine the quality differences of 8 kinds of preparations. Methods Phenomenex Luna NH _ 2 column (4.6 mm 脳 250mm ~ 5 渭 m),) -acetonitrile (25:75) -acetonitrile (25:75) was used as mobile phase with phosphate buffer solution (7.0 g dipotassium hydrogen phosphate dissolved in proper amount of water, adding 0.5 mL ammonia water, diluted to 2 000 mL with water, adjusted pH value to 7.5 mm with phosphoric acid). The flow rate was 1.5 mL / min ~ (-1), the column temperature was 30 鈩，

本文编号：2109774