高效液相色谱法测定复方二甲双胍格列本脲片中杂质双氰胺的含量

Determination of Foreign Substance Dicyanodiamide in Compound Metformin and Glibenclamide Tablets by HPLC

目的：建立以高效液相色谱法测定复方二甲双胍格列本脲片中杂质双氰胺含量的方法。方法：色谱柱为Maeherey-Nagel不锈钢柱，流动相为甲醇-1．7％磷酸二氢铵（30：70），检测波长为218nm，流速为1．0ml／min，进样量为20μl，柱温为室温。结果：双氰胺检测浓度在0．0625～1．000μg／ml范围内线性关系良好，平均加样回收率为96．53％（RSD=1．66％）。结论：本方法灵敏度高，结果准确、可靠，专属性强，操作简便、快速，适合于复方二甲双胍格列本脲片中杂质双氰胺的含量测定。

OBJECTIVE： To establish a HPLC method for the determination of foreign substance dicyanodiamide in compound metformin and glibenclamide tablets.METHODS;The determination was performed on Maeherey-Nagel stainless steel column, the mobile phase consisted of MeOH - 1.7% ammonium dihydrogen phosphate（30 ： 70）,with a detection wavelength at 218nm and a flow rate at 1.0ml/min, the sample size was 20μl and the column was at room temperature .RESULTS： The linear detection concentration range of dicyanodiamide was 0.0625～1.000μg/ ml.The average recovery rate was 96.53% （RSD = 1.66% ） .CONCLUSIONS： The method is sensitive, accurate, reliable, specific, simple and rapid, and suitable for the determination of foreign substance dicyanodiamide in compound metformin and glibenclamide tablets.