HPLC测定盐酸氨基葡萄糖有关物质与含量  

Determination of Related Substances and Content of Glucosamine Hydrochloride by HPLC

作　　者：沈丹丹 曾杰 王玥[3] 张涛 SHEN Dan-dan ZENG Jie WANG Yue ZHANG Tao(Changqing Institute for Food and Drug Control, Chongqing 401121, China Chongqing Research Center for Drug Process and Quality Control Engineering, Chongqing 401121, China Central South University, Changsha 410013, China Fuan Pharmaceutical Lybon Pharm-tech Co.,Ltd, Chongqing 401121, China)

机构地区：[1]重庆市食品药品检验检测研究院,重庆401121 [2]重庆市药物过程与质量控制工程技术研究中心,重庆401121 [3]中南大学,长沙410013 [4]福安药业集团重庆礼邦药物开发有限公司,重庆401121

出　　处：《中国药学杂志》2017年第4期314-318,共5页Chinese Pharmaceutical Journal

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。OBJECTIVE To establish an HPLC method for determination of the related substances and content of glucosamine hydrochloride products from different manufacturers,and evaluate the quality variation of products of three dosage forms from eight different manufacturers. METHODS The determination method was developed on a Phenomenex Luna NH2column（ 4. 6 mm × 250 mm,5μm）,with phosphate buffer（ 7. 0 g dipotassium hydrogen phosphate dissolved in a suitable amount of water,diluted with 0. 5 m L ammonia,add water to 2 000 m L,adjusted to p H 7. 5 with phosphoric acid）-acetonitrile（ 25∶ 75） as mobile phase at a flow rate of 1. 5 m L·min（-1）. The column temperature was maintained at 30 ℃ and detection wavelength was set at 195 nm. RESULTS The system suitability test met the requirements,and the resolution between the peaks of glucosamine hydrochloride and the impurities were greater than 1. 5.Good linearity was shown for glucosamine hydrochloride in the concentration range of 0. 156 64（-1）5. 664 mg·m L（-1）（ r =0. 999 9）. The average recovery rate was 101. 14%,with RSD of 1. 20%（ n = 9）. CONCLUSION The established method can be applied in the simultaneous determination of the related substances and content of glucosamine hydrochloride products and provide reference for the quality control.

关 键 词：盐酸氨基葡萄糖 N-乙酰氨基葡萄糖 脱氧果糖 含量测定 高效液相色谱法 质量控制 

分 类 号：R917[医药卫生—药物分析学]