高效液相色谱法测定盐酸二甲双胍片中杂质F含量  

Determination of impurity F in metformin hydrochloride tablets by high performance liquid chromatography

作　　者：杨荣杰[1] 刘东平 杨荣艳[3] YANG Rongjie;LIU Dongping;YANG Rongyan(Siping Infectious Disease Hospital,Siping Jilin,136000,China;Jilin Jichun Pharmaceutical Limited Company;Siping Institute for Food and Drug Control)

机构地区：[1]四平市传染病医院,吉林四平136000 [2]吉林吉春制药股份有限公司 [3]四平市食品药品检验所

出　　处：《质量安全与检验检测》2025年第1期27-30,共4页QUALITY SAFETY INSPECTION AND TESTING

摘　　要：本文建立高效液相色谱法(HPLC)测定盐酸二甲双胍片中杂质F(二甲胺)含量。以2,4-二硝基氟苯为衍生化试剂,对样品进行柱前衍生化,采用紫外检测器-高效液相色谱法分析,C_(18)色谱柱(4.6×250 mm,5μm),以0.1%磷酸-乙腈为流动相进行梯度洗脱,检测波长为380 nm,流速为0.7 m L/min,柱温为30℃。结果显示,杂质F在0.01~1.00μg/m L质量浓度范围内与其峰面积线性关系良好(r=0.9999)。检测限为0.015 ng,定量限为0.050 ng;平均样品回收率为102.4%,RSD为2.4%(n=9)。由此可见,该方法操作简单,灵敏度高,重复性好,可用于盐酸二甲双胍片中杂质F含量的测定。A high performance liquid chromatography(HPLC)method was established for the determination of impurity F(dimethylamine)in metformin hydrochloride tablets.The samples were pre-column derivatized with fluorodinitrobenzene as derivatization reagent,and analyzed by UV detector-high performance liquid chromatography.C_(18) chromatographic column(4.6×250 mm,5μm)was used with 0.1%phosphoric acid-acetonitrile as mobile phase for gradient elution.The detection wavelength was 380 nm,the flow rate was 0.7 mL/min,and the column temperature was 30℃.The results showed that im-purity F had a good linear relationship with its peak area in the mass concentration range of 0.01-1.00μg/mL(r=0.9999).The limit of detection was 0.015 ng and the limit of quantitation was 0.050 ng.The average recovery was 102.4%,RSD=2.4%(n=9).Therefore,this method is simple,sensitive and reproducible,and can be used for the determination of impurity F in metformin hydrochloride tablets.

关 键 词：衍生化法 高效液相色谱法 盐酸二甲双胍片 二甲胺 含量 

分 类 号：R927.2[医药卫生—药学]