阿立哌唑中N,N-二甲基甲酰胺含量测定方法及方法学验证  

Determination of N,N-Dimethylformamide in Aripiprazole and Methodological Validation

作　　者：王涛 刘晓宇 陈鹏 汪华 钟旭斌 郭小君 Wang Tao;Liu Xiaoyu;Chen Peng;Wang Hua;Zhong Xubin;Guo Xiaojun(Livzon Syntpharm Co.,Ltd.(Zhuhai FTZ),Guangdong Zhuhai 519030,China;Institute of Teacher Education,Taishan University,Tai'an,271021,China)

机构地区：[1]珠海保税区丽珠合成制药有限公司,广东珠海519030 [2]泰山学院教师教育研究院,山东泰安271021

出　　处：《云南化工》2023年第3期77-79,共3页Yunnan Chemical Technology

摘　　要：阿立哌唑是一种抗精神病类药物,既可用于治疗精神分裂症,也可用于双相I型情感障碍的躁狂发作或混合发作急性期或维持期的治疗。N,N-二甲基甲酰胺在阿立哌唑中大量残留会导致人体出现出现头痛、焦虑、呕吐等症状,较严重的会对肝脏造成损害。通过对高效液相色谱中洗脱程序的设计和溶解阿立哌唑的溶解剂进行筛选,确定了阿立哌唑中N,N-二甲基甲酰胺含量测定的洗脱程序和以四氢呋喃为溶解剂。同时,为了验证该方法测定的可行性,进行了专属性、精密度、定量限与检测限、线性与范围、准确度、耐用性、溶液稳定性等方法学验证实验,实验结果表明:该方法对于测定阿立哌唑中N,N-二甲基甲酰胺含量具有可行性。Aripiprazole is an antipsychotic drug,which can be used not only for the treatment of schizophrenia,but also for the treatment of manic episode or mixed episode of bipolar I affective disorder in the acute or maintenance phase.A large amount of N,N-dimethylformamideresidue in aripiprazole will cause headache,anxiety,vomiting and other symptoms in the human body,and more serious,will cause damage to the liver.We determined the elution procedure for the determination of N,N-dimethylformamide content in aripiprazole by designing the elution procedure in the liquid phase and selected tetrahydrofuran as the solvent for dissolution of aripiprazole.At the same time,in order to validate the method procedures,Methodological validation experiments on specificity,precision,quantification limit,detection limit,linearity,range,accuracy,durability and solution stability were conducted.The method was proved to be feasible for the determination of N,N-dimethylformamide in aripiprazole.

关 键 词：阿立哌唑 N N-二甲基甲酰胺 高效液相色谱 方法学验证 

分 类 号：O657[理学—分析化学]