高效液相色谱法测定马西替坦中N,N-二甲基苯胺含量  

Determination of N,N-dimethylaniline in Macitentan by HPLC

作　　者：程蕤 姜辉[2] 周晶 李霁明 汪琛媛[1] Cheng Rui;Jiang Hui;Zhou Jing;Li Jiming;Wang Chenyuan(Department of Medicine,the First Affiliated Hospital of Anhui College of Traditional Chinese Medicine,Hefei 230031,China)

机构地区：[1]安徽中医药大学第一附属医院药学部,合肥230031 [2]安徽中医药大学第一附属医院科研科,合肥230031

出　　处：《中国临床保健杂志》2019年第4期500-503,共4页Chinese Journal of Clinical Healthcare

基　　金：安徽省高等学校省级自然科学研究(重点)项目(KJ2015A0598)

摘　　要：目的 建立高效液相色谱法(HPLC)测定马西替坦中N,N-二甲基苯胺的含量。方法 采用高效液相色谱法,色谱柱为菲罗门LunaC18色谱柱(250mm×4.6mm,5μm),流动相为水(用磷酸调节pH值至2.5)∶乙腈=20∶80,检测波长254nm,柱温30℃。结果 N,N-二甲基苯胺在0.031~0.937μg/mL范围内线性关系良好(r=0.9995,n=5),平均回收率为99.58%,RSD为1.22%(n=9)。结论 HPLC可作为马西替坦中N,N-二甲苯胺含量测定方法。Objective To establish HPLC method for determining the content of N,N-dimethylaniline in Macitentan. Methods HPLC was performed on a Phenomenex Luna C 18 column(250mm × 4.6mm,5 μm).The mobile phase is water (Adjust pH to 2.5 with phosphoric acid)- acetonitrile(20∶ 80).The detection wavelength is 254 nm,and the column temperature is 30 ℃. Results The linear of N,N-dimethylanilinewas in the rangefrom 0.031 to 0.937 μg/mL( r =0.9995, n =5).The average recovery was 99.58%,with RSD was 1.22%( n =9). Conclusions The HPLC can be used as a method for determining the content of N,N-dimethylaniline in Macitentan.

关 键 词：高血压 肺性 气相色谱-质谱法 内皮素受体拮抗剂 

分 类 号：R927.2[医药卫生—药学] O657.72[理学—分析化学]