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。
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.
出处
《中国药房》
CAS
北大核心
2015年第12期1716-1718,共3页
China Pharmacy
关键词
盐酸二甲双胍缓释片
双氰胺
有关物质
HPLC
Metformin hydrochloride sustained-release tablets
Dicyandiamide
Related substances
HPLC