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目的:建立HPLC法同时测定复方对乙酰氨基酚片中对乙酰氨基酚、乙酰水杨酸和咖啡因的含量。方法:采用EliteC_(18)色谱柱(150 mm×4.6 mm,5μm),流动相为1%醋酸溶液(用三乙胺调节pH至3.7)-甲醇(65:35);检测波长272 nm;流速1.0 ml·min~(-1)。结果:对乙酰氨基酚、乙酰水杨酸和咖啡因的线性范围分别为0.19～2.92μg(r=0.999 4),0.34～5.23μg(r=0.9999),0.04～0.61μg(r=0.9999)。平均回收率分别99.8%(RSD=0.6%),100.2%(RSD=0.9%),101.5%(RSD=0.6%)(n=6)。结论:本方法快速、简便、准确,可作为该制剂的质量控制方法。
Objective: To establish an HPLC method for simultaneous determination of paracetamol, acetylsalicylic acid and caffeine in acetaminophen tablets. Methods: The mobile phase consisted of 1% acetic acid (adjusted to pH 3.7 with triethylamine) -methanol (65:35) using EliteC 18 column (150 mm × 4.6 mm, 5 μm) 1.0 ml · min ~ (-1). Results: The linear range of acetaminophen, acetylsalicylic acid and caffeine were 0.19 ~ 2.92μg (r = 0.999 4), 0.34 ~ 5.23μg (r = 0.9999) and 0.04 ~ 0.61μg (r = 0.9999) respectively. The average recovery rates were 99.8% (RSD = 0.6%), 100.2% (RSD = 0.9%) and 101.5% (RSD = 0.6%), respectively (n = 6). Conclusion: The method is rapid, simple and accurate and can be used as the quality control method of this preparation.