19F核磁共振定量技术测定泮托拉唑钠含量  

Determination of pantoprazole sodium by F quantitative nuclear magnetic resonance

作　　者：刘阳[1] 白洁[2] 刘静[1] 何兰[1] LIU Yang;BAI Jie;LIU Jing;HE Lan(National Institutes for Food and Drug Control,NMPA Key Laboratory for Quality Research and Evaluation of Chemical Drugs,Beijing 102629,China;Lanzhou University,Lanzhou 730000,China)

机构地区：[1]中国食品药品检定研究院,国家药品监督管理局化学药品质量研究与评价重点实验室,北京102629 [2]兰州大学,兰州730000

出　　处：《药物分析杂志》2020年第11期1948-1951,共4页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立用19F核磁共振定量技术测定泮托拉唑钠含量的方法。方法:以氟化钠为内标,水为溶剂,进行19F核磁共振谱测定,通过比较泮托拉唑钠样品定量峰信号与内标物氟化钠响应峰信号面积,计算泮托拉唑钠的含量,并进行方法学验证。结果:泮托拉唑钠质量浓度在0.4~16 mg·mL^-1范围内线性关系良好,精密度RSD为0.39%(n=5),重复性RSD为0.84%(n=5)。19F核磁共振定量测定结果为94.7%,与质量平衡法结果95.3%基本一致。结论:19F核磁共振定量法可用于测定泮托拉唑钠的含量,且方法准确、简单、高效,无需自身对照物。Objective:To establish a method for the determination of pantoprazole sodium by 19F quantitative NMR technique.Methods:The 19F nuclear magnetic resonance spectrum was determined by using sodium fluoride as the internal standard and deuterated water as the solvent.The pantoprazole sodium content was calculated by comparing the response peak area of sample and internal standard.Method validation was accomplished.Results:A method for the determination of pantoprazole sodium by 19F quantitative NMR technique was established.The linear relationship of pantoprazole sodium in the range of 0.4-16 mg·m L^-1 was good,the RSD of injection precision was 0.39%(n=5),and the RSD of repeatability was 0.84%(n=5).The result from 19F quantitative NMR can 94.7%and was consistent with the result from mass balance method(95.3%).Conclusions:The 19F quantitative NMR can be used to determine the content of pantoprazole sodium,which is precise,simple,efficient and no need for self-control.

关 键 词：19F核磁共振定量 泮托拉唑钠 含量测定 内标 方法学验证 

分 类 号：R917[医药卫生—药物分析学]