离子色谱法测定盐酸二甲双胍药物中二甲胺的含量  

Determination of dimethylamine in metformin hydrochloride by ion chromatography

作　　者：储韫婧 邵方娴 陈民辉 冯芳[1] CHU Yun-jing;SHAO Fang-xian;CHEN Min-hui;FENG Fang(Department of Pharmaceutical Analysis,China Pharmaceutical University,Nanjing 211198;Jiangsu Institute for Food and Drug Control,Nanjing 210019)

机构地区：[1]中国药科大学药物分析教研室,南京211198 [2]江苏省食品药品监督检验研究院,南京210019

出　　处：《中南药学》2022年第5期1162-1166,共5页Central South Pharmacy

摘　　要：目的建立离子色谱法测定盐酸二甲双胍药物中二甲胺的含量。方法采用阳离子交换柱Dionex IonPac CS12A(4 mm×250 mm),以甲磺酸溶液为淋洗液进行梯度洗脱,流速1.0 mL·min^(-1),柱温30℃,进样体积25μL,采用抑制型电导器检测。结果原料、胶囊及片剂中的二甲胺在0.050~50μg·mL^(-1)与峰面积线性关系良好(r=1.000),定量限和检测限分别为6 ng·mL^(-1)和2 ng·mL^(-1)。缓释片中的二甲胺在0.025~5.0μg·mL^(-1)与峰面积线性关系良好(r=0.9990),定量限和检测限分别为6 ng·mL^(-1)和3 ng·mL^(-1)。原料及制剂中二甲胺的回收率在92.5%~103.5%,RSD<4.0%。结论该方法操作简便,准确可靠,可用于盐酸二甲双胍药物中二甲胺含量的检测。Objective To determine the dimethylamine(DMA)in metformin hydrochloride by ion chromatography method.Methods The determination was conducted on a Dionex IonPac CS12A(4 mm×250 mm)column and a protective column[Dionex IonPac CG12A(4 mm×50 mm)]with methanesulfonic acid solution as the eluent.The flow rate was 1.0 mL·min^(-1).The column temperature was 30℃,and the injection volume was 25μL.Results In non-sustained released dosage forms,the method showed good linearity at 0.050~50μg·mL^(-1)(r=1.000)for DMA,the limit of quantification and detection were 6 ng·mL^(-1) and 2 ng·mL^(-1),respectively.In sustained released dosage forms,the method showed good linearity at 0.025~5.0μg·mL^(-1)(r=0.9990)for DMA,the limit of quantification and detection were 6 ng·mL^(-1) and 3 ng·mL^(-1),respectively.The recoveries of raw materials and its preparations ranged from 92.5%to 103.5%with the RSD less than 4.0%.Conclusion The method is simple,accurate and reliable for the determination of DMA in metformin hydrochloride and its preparations.

关 键 词：离子色谱法 抑制电导 盐酸二甲双胍 二甲胺 

分 类 号：R927[医药卫生—药学]