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目的:采用色谱-质谱联用技术对萘普生钠中强制破坏后的降解产物进行结构鉴定。方法:采用CAPCELL PAK C_(18)色谱柱(250 mm×4.6 mm,5μm),以乙腈-水-甲酸(48∶52∶0.1)为流动相,检测波长为262 nm,流速为1.0 mL·min~(-1),柱温35℃,进样量20μL,对萘普生钠的降解产物进行分离。同时,采用HPLC-QTOF MS对萘普生钠的主要降解产物进行定性研究。结果:在该色谱条件下,各降解产物峰和萘普生钠峰达到有效分离,并初步鉴定出萘普生钠中4个主要降解产物的结构。结论:本法可用于测定萘普生钠的降解产物,并对其药品质量控制提供了参考依据。
OBJECTIVE: To identify the degradation products of naproxen sodium after forced destruction by chromatography-mass spectrometry. Methods: CAPCELL PAK C 18 column (250 mm × 4.6 mm, 5 μm) was used with acetonitrile-water-formic acid (48:52:0.1) as the mobile phase at a detection wavelength of 262 nm and a flow rate of 1.0 mL · min ~ (-1) column temperature 35 ℃, injection volume 20μL, the degradation of naproxen sodium products were isolated. At the same time, the main degradation products of naproxen sodium were qualitatively studied by HPLC-QTOF MS. Results: Under the chromatographic conditions, the peak of each degradation product and the peak of naproxen sodium were effectively separated, and the structures of four major degradation products of sodium naproxen were identified preliminarily. Conclusion: This method can be used for the determination of naproxen sodium degradation products, and provide a reference for the quality control of the drug.