盐酸二甲双胍缓释片中双氰胺及有关物质的测定

发布时间：2018-07-04 16:55

  本文选题：盐酸二甲双胍缓释片 + 双氰胺　； 参考：《中国药房》2015年12期

【摘要】：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。
[Abstract]:Objective: to establish a method for the determination of dicyandiamide and its related substances in metformin hydrochloride sustained-release tablets. Methods: high performance liquid chromatography was used. The chromatographic column was Venusil SCX sulfonic acid cation exchange column, the mobile phase was 1.7% ammonium dihydrogen phosphate solution (adjusted by phosphoric acid to pH 3.0), the flow rate was 1.0 ml / min, the detection wavelength was 218 nm, the column temperature was 40 鈩，

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