目的: 采用核磁共振氢谱法测定盐酸阿芬太尼注射液主成分的含量。方法: 在Bruker 600 MHz液体核磁共振波谱仪上,采用改进的Watergate-W5脉冲序列和PULCON技术,循环延迟时间（D1）为36 s,累加（NS）8次。以马来酸为内标物,采集盐酸阿芬太尼注射液的水峰压制定量核磁氢谱（1H-qNMR）,对主成分进行定量分析。结果: 该方法主成分峰与内标峰分离度好,精密度较高,重复性较好,线性相关系数0.999 9,测定阿芬太尼含量为98.2%~101.2%。结论: 本文建立的核磁定量法样品处理简单,快速准确,为盐酸阿芬太尼注射液含量测定提供了新方法。
Objective: To determine the content of alfentanil hydrochloride in injection form using proton nuclear magnetic resonance (1H-qNMR) spectroscopy. Methods: The contents of alfentanil were determined by quantitative proton nuclear magnetic resonance (1H-qNMR) with water suppression. Spectra were acquired on a Bruker 600 MHz liquid-state NMR spectrometer using an improved Watergate-W5 pulse sequence combined with the PULCON technique. The relaxation delay (D1) was set to 36 s, and 8 scans were accumulated. Maleic acid was used as the internal standard. Results: The 1H-qNMR signals of the main component and internal standard showed good separation, with high precision and reproducibility. The method demonstrated good linearity, with a correlation coefficient of 0.9999. The measured content of alfentanil ranged 98.2%-101.2%. Conclusion: The 1H-qNMR method established in this study is simple, rapid and accurate, and provides a new approach for the quantitative determination of alfentanil hydrochloride injection.
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