离子色谱法测定富马酸贝达喹啉中二甲胺的含量

Determination of Dimethylamine Assay in Bedaquiline Fumarate by Ion Chromatography

目的:对富马酸贝达喹啉中二甲胺的含量进行测定。方法采用离子色谱法,阳离子色谱柱(Dionex IonPac CS12A 4×250mm);以10mmol/L甲磺酸溶液为流动相,流速为1.0mL/min;柱温为30℃;检测器为电导检测器,检测器温度为35℃。;结果:富马酸贝达喹啉与二甲胺无干扰,峰面积与浓度在一定的范围内均呈良好的线性关系。结论:该方法作为富马酸贝达喹啉中二甲胺含量的检测方法准确、可靠。

Objective:To establish a method for detection of dimethylamine assay in Bedaquiline fumarate.Methods:The dimethylamine assay in Bedaquiline fumarate was determined by IC with Cation chromatography column(Dionex IonPac CS12A 4×250mm);the mobile phase was 10mmol/L methylsulfonic acid water solution and column temperature was 25℃;Conductivity detector was used;The flow rate was 1.0mL/min;detector temperature was 35℃;Results:Bedaquiline fumarate and dimethylamine without interference,and the calibration curves hand good liner relationship within a certain range Conclusion:this method is proved accurate and reliable,it can be used for the determination of dimethylamine assay in Bedaquiline fumarate.