核磁共振定量法测定制剂中埃索美拉唑含量

Determination of the content of esomeprazole in preparations by quantitative nuclear magnetic resonance(qNMR)

以马来酸为内标,氘代二甲基亚砜为溶剂测定1H核磁共振谱,通过比较样品定量峰与内标物质响应峰峰面积,计算埃索美拉唑的含量。结果显示,同一样品在相同条件下测定6次,定量峰与内标响应峰比值的RSD为0.54%;平行配制5份样品溶液,定量峰与内标响应峰比值的RSD为0.62%。采用不同样品定量峰计算的埃索美拉唑含量分别97.2%、97.1%、98.2%、98.1%,RSD分别为0.54%、0.62%、1.33%、1.28%。本文建立的核磁共振定量法(q NMR法)可以有效避免辅料依地酸二钠、氢氧化钠干扰,经方法验证可用于测定埃索美拉唑含量。

Maleic acid was used as an internal standard,DMSOd6 as solvent in 1 HNMR to characterize esomeprazole,and calculate the content of esomeprazole by comparing the response peak area of sample(As)and internal standard(Ar).As a result,One sample solution was characterized under the same NMR conditions for six times,RSD of As/Ar was 054%.For five sample solutions which were parallel prepared,RSD of As/Ar was 0.62%.Meanwhile,based on different peaks,the content of esomeprazole calculated was 97.2%,97.1%,98.2%and 98.1%respectively,RSD was 0.54%,0.62%,1.33%and 1.28%respectively.Using qNMR to characterize the content of esomeprazole can avoid the effect of disodium edetate and sodium hydroxide.This method can be used for determination of the content of esomeprazole according to the method validation.