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目的建立马来酸氯苯那敏及有关物质的含量测定方法。方法采用固相萃取-高效液相色谱法,EclipseXDB-C18色谱柱(4.6mm×150mm,5μm)。流动相:甲醇-醋酸三乙胺溶液(45∶55)。检测波长:261nm。结果线性范围为1.02～16.32μg·mL-1,r=0.9999。低、中、高3个浓度的平均回收率为(103.05±1.24)%,(100.87±1.45)%,(99.63±1.03)%。结论本方法简便快速、专属性好、重复性好、易操作。
Objective To establish a method for the determination of chlorpheniramine maleate and its related substances. Methods Solid phase extraction - high performance liquid chromatography (HPLC) was used with EclipseXDB-C18 column (4.6mm × 150mm, 5μm). Mobile phase: methanol-triethylamine acetate solution (45:55). Detection wavelength: 261nm. The linear range of results was 1.02 ~ 16.32μg · mL-1, r = 0.9999. The average recoveries of low, medium and high concentrations were (103.05 ± 1.24)%, (100.87 ± 1.45)% and (99.63 ± 1.03)%, respectively. Conclusion The method is simple, rapid, specific, reproducible and easy to operate.