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建立了同时测定酚氨咖敏片中对乙酰氨基酚、氨基比林、咖啡因和马来酸氯苯那敏4组分含量的毛细管气相色谱法。采用SE-30大口径毛细管色谱柱(30 m×0.53 mm,1.0μm),柱温190℃,汽化室温度220℃,检测器为FID,检测温度250℃,载气为高纯N2,分流比为1∶6,内标为盐酸麻黄碱,以无水乙醇为溶剂,样品无需衍生化处理,直接进样测定。样品中各组分完全分离,辅料无干扰,对乙酰氨基酚、氨基比林、咖啡因和马来酸氯苯那敏分别在20~2000μg/mL、15~1500μg/mL、10~500μg/mL和20~100μg/mL范围内线性关系良好(r>0.999),各组分的平均回收率在99.6%~101.2%范围内,RSD<2%。
A capillary gas chromatographic method was developed for the simultaneous determination of paracetamol, aminopyrine, caffeine and chlorpheniramine maleate in the phenolphthalocyanine tablets. The capillary column of SE-30 (30 m × 0.53 mm, 1.0 μm) was used. The column temperature was 190 ℃ and the temperature of vaporization chamber was 220 ℃. The detector was FID, the detection temperature was 250 ℃, the carrier gas was high purity N2, 1: 6, the internal standard for ephedrine hydrochloride, ethanol as solvent, the sample without derivatization, direct injection determination. The components in the sample were completely separated and the excipients were not disturbed. The concentrations of acetaminophen, aminopyrine, caffeine and chlorpheniramine maleate were 20 ~ 2000μg / mL, 15 ~ 1500μg / mL, 10 ~ 500μg / mL (R> 0.999) in the range of 20-100 μg / mL. The average recovery of each component ranged from 99.6% to 101.2% with RSD <2%.