HPLC法测定药用辅料蔗糖八醋酸酯的含量 - 中国药房.PDF

HPLC 法测定药用辅料蔗糖八醋酸酯的含量 ＊ 冯丰凑 ，李曙光，于 玥，邬晓鸥，李 军（深圳市药品检验所/ 深圳药品质量标准研究重点实验室，广东深圳 518057） 中图分类号 R927.1 文献标志码 A 文章编号 1001-0408（2014）17-1624-02 DOI 10.6039/j.issn. 1001-0408.2014.17.29 摘 要 目的：建立测定药用辅料蔗糖八醋酸酯含量的方法。方法：采用高效液相色谱法。色谱柱为MG ⅡC18，流动相为乙腈-水 （75∶25，V/ V），流速为1.0ml/min ，柱温为30℃，检测波长为210nm ，进样量为20μl。检测3批样品含量并与《美国药典》方法（剩余 滴定法）比较。结果：蔗糖八醋酸酯检测质量浓度线性范围为1.0～10mg/ml （r ＝0.9999），平均回收率为100.8％，RSD 为0.5％ （n ＝3）。本法与《美国药典》法测定结果比较，后者值高约1％，估计为包含的杂质量。结论：本法操作简便、专属性强、重复性好， 准确度优于《美国药典》法，能够有效控制蔗糖八醋酸酯的质量。 关键词 高效液相色谱法；蔗糖八醋酸酯；含量测定；剩余滴定法 Content Determination of Pharmaceutical Adjuvant Sucrose Octaacetate by HPLC FENG Feng-cou ，LI Shu-guang ，YU Yue ，WU Xiao-ou ，LI Jun （Shenzhen Institute for Drug Control/Shenzhen Key Laboratory of Drug Quality Standard Research ，Guangdong Shenzhen 518057，China ） ABSTRACT OBJECTIVE ：To establish the method for the content determination of pharmaceutical adjuvant sucrose octaacetate. METHODS ：HPLC method was adopted. The determination was performed on MG ⅡC18 column with mobile phase consisted of acetonitrile-water （75∶25，V/ V）at the flow rate of 1.0 ml/min. The column temperature was 30 ℃，and the detection wavelength was set at 210nm. The sample size was 20 μl. The contents of 3batches of samples were determined ，and compared with the meth- od stated in United States Pharmacopeia. RESULTS ：The linear range of sucrose octaacetate was 1.0-10mg/ml （r ＝0.999 9）with an average recovery of 100.8％ （RSD ＝0.5％，n ＝3）. The content of sucrose octaacetate determined by the method of United States Pharmacopeia was 1％above higher than this method ；this value may contain the weight of impurity. CONCLUSIONS ：The method is simple ，specific and reproducible ，and can control the quality of sucrose octaacetate effectively. The accuracy of it is bet- ter than that of United States Pharmacopeia. KEYWORDS HPLC ；Sucrose octaacetate ；Content det