盐酸二甲双胍缓释片中双氰胺及有关物质的测定

Determination of Dicyandiamide and Related Substances in Metformin Hydrochloride Sustained-release Tablets

目的：建立测定盐酸二甲双胍缓释片中双氰胺及有关物质的方法。方法：采用高效液相色谱法。色谱柱为Venusil SCX磺酸基阳离子交换柱,流动相为1.7%磷酸二氢铵溶液（磷酸调节p H至3.0）,流速为1.0 ml/min,检测波长为218 nm,柱温为40℃,进样量为20μl。结果：双氰胺、盐酸二甲双胍进样量分别在0.105 2-10.52、0.509-50.9 ng范围内与各自峰面积呈良好线性关系（r=0.999 9、0.999 8）;精密度、重复性、稳定性试验的RSD均小于2%;双氰胺平均回收率为100.5%,RSD=1.87%（n=9）。结论：该方法简便快速、灵敏度高、专属性强,可用于盐酸二甲双胍缓释片中双氰胺及有关物质的测定。

OBJECTIVE：To develop a method for the determination of dicyandiamide and related substances in Metformin hydrochloride sustained-release tablets. METHODS：The HPLC method was performed on a Venusil SCX sulfonic acid based cationic ion-exchange column with the mobile phase of 1.7% ammonium dihydrogen phosphate（adjusted p H=3.0 by phosphoric acid）at the flow rate of 1.0 ml/min;the detection wavelength was 218 nm,the temperature was 40 ℃ and the volume was 20 μl. RESULTS：There was a good linear relationship between the volume of dicyandiamide and metformin hydrochloride and the peak area in the range of 0.105 2-10.52 and 0.509-50.9 ng（r=0.999 9,0.999 8）;the RSDs of precision,repeatability and stability test were all less than 2%;the average recovery of dicyandiamide was 100.5%（RSD=1.87%,n=9）. CONCLUSIONS：This method is simple,rapid,sensitive,specialty and can be used to determine dicyandiamide and related substances of Metformin hydrochloride sustained-release tablets.