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.
LÜ Zhen-xing
,
HUNG Tao
,
LIU Chen-xi
,
ZHAO Ya-ping
,
ZHANG Xu
,
ZENG Dan-yun
,
DU Tian-peng
. Quantitative determination of alfentanil hydrochloride injection by proton nuclear magnetic resonance spectroscopy*[J]. Chinese Journal of Pharmaceutical Analysis, 2025
, 45(7)
: 1191
-1196
.
DOI: 10.16155/j.0254-1793.2024-1121
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