【摘要】 建立了测定奈玛特韦原料药绝对含量的定量核磁共振氢谱法（¹H qNMR）。基于奈玛特韦在溶液中的构象稳定条件，以DMSO-D₆和D₂O（5∶1，体积比）为溶剂，δ4.96（1H,dd）和δ4.67（1H,dd）处的质子信号作为奈玛特韦的定量峰，δ6.22（1H,t）和δ5.84（1H,d）为拉米夫定的内标峰。样品与内标摩尔比在0.5∶1.0～1.2∶1.0范围时的线性拟合方程为Y=0.456 4X-0.000 5（r²=0.999 9），该方法专属性强，耐用性、重复性良好，回收率满足要求，稳定性可达48 h。该方法测得的奈玛特韦样品的含量为99.23%（相对标准偏差为0.24%）。¹H qNMR法操作简单，具有无损、准确快速的特点，适用于新药奈玛特韦绝对含量的测定。更多还原

【Abstract】 A quantitative nuclear magnetic resonance（¹H qNMR） method was developed for the determination of the absolute content of nirmatrelvir API.Based on the conformationally stable conditions of nemativir in solution,the proton signals at δ4. 96（1H,dd）,δ4. 67（1H,dd） and δ6. 22（1H,t）,δ5. 84（1H,d） were selected as the quantitative peaks for nirmatrelvir and lamivudine respectively in DMSO-D₆ and D₂O（5∶1,by volume） solvents on BRUKER AV-500 NMR instrument.The qNMR method exhibited a high specificity,and an linear fitting equation Y = 0. 456 4X-0. 000 5（r² = 0. 999 9） was obtained in the range of 0. 5∶1. 0-1. 2∶1. 0 for the molar ratio of sample to internal standard,and the results showed good durability,reproducibility,recovery and 48-hour stability.The content of nirmatrelvir was determined to be 99. 23%（RSD = 0. 24%） by qNMR.The ¹H qNMR method is simple,non-destructive,accurate and rapid,which is suitable for determination on the absolute content of nirmatrelvir API.更多还原