目的: 建立用19F qNMR技术测定草酸艾司西酞普兰及其杂质对照品含量的方法。方法: 以4-氟肉桂酸为内标,DMSO为溶剂,采用Bruker Avance NEO 600型核磁共振谱仪,进行氟谱测定,计算草酸艾司西酞普兰及其杂质的含量。结果: 该方法用于测定草酸艾司西酞普兰及其杂质线性关系良好,精密度高,重复性好。19F qNMR测定草酸艾司西酞普兰及其杂质Ⅰ、Ⅱ、Ⅳ、Ⅳ对照品的含量结果分别为99.40%、99.35%、96.59%、97.02%、90.36%。结论: 19F qNMR法可用于测定草酸艾司西酞普兰及其杂质的含量,且方法准确、简单、高效、经济、环保。
Objective: To establish an 19F quantitative nuclear magnetic resonance(19F qNMR) method for the determination of escitalopram oxalate and its impurities reference substance. Methods: Using 4-fluorocinnamic acid as the internal standard and DMSO as the solvent, 19F NMR spectra were obtained by Bruker Avance NEO 600 spectrometer to measure the content of escitalopram oxalate and its impurities. Results: This method had a good linear relationship, high precision and good repeatability for determination of escitalopram oxalate and its impurities. The contents of reference substances for escitalopram oxalate and its impurities Ⅰ, Ⅱ, Ⅳ and Ⅳ were 99.40%, 99.35%, 96.59%, 97.02% and 90.36% respectively using 19F qNMR method. Conclusion: The 19F qNMR method can be used to determine the contents of escitalopram oxalate and its impurities, and the method is accurate, simple, efficient, economic and environmental friendly.
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