HPLC法测定盐酸二甲双胍肠溶微丸胶囊中双氰胺的含量

HPLC determination of dicyandiamide in metformin hydrochloride enteric-pellets capsules

目的:建立HPLC法测定盐酸二甲双胍肠溶微丸胶囊中的有关物质(双氰胺)的含量方法。方法:色谱条件为:Inertsil-ODS-3(4.6mm×150mm,5μm),流动相为乙腈-0.05%庚烷磺酸钠水溶液(16∶84),检测波长218nm,流速1mL·min^(-1)。结果:进样量在0.5～5ng时,与峰面积线性关系良好,r=0.9998(n=6)。平均回收率99.4%,精密度RSD=0.5%(n=6)。

Objective：To determine the method of related substances （dicyandiamide） of metformin hydrochloride enteric - pellets capsules by HPLC. Method： Condition of the HPLC method was ： Inertsil - ODS - 3 （4. 6 mm ×150mm,5μm） was used, aeconitril -0. 05% sodium heptanesulfonate（ 16： 84） as the mobile phase, at detection wavelength 218 nm, at a flow rate of 1 mL ·min^-1 Results.The linearity of peak area was good when the injected quantity of dicyandiamide was in the rang of 0. 5 -5 ng（ r = 0. 9998 n = 6）. The recovery of this method was 99.4%, the precision RSD =0.5% （n =6）.