Objective To establish a quality control method for simultaneous determination of caffeine and paracetamol in Compound Paracetamol and Chlorphenamine through high performance liquid chroma-tography (HPLC) .Methods The chromatographic column was C18 (4 .6mm × 150mm ,5μm) ,the mobile phase was methanol (A)/water (B) ( 25/75) ,the detection wave length was 214nm ,the column tempera-ture was 25 ℃ ,the flow rate was 0 .6ml/min and the sample size was 10μl .Results The contents of caffeine and acetaminophen were 0 .030~0 .295μg and 0 .763~7 .625μg respectively ,showing good linear relation-ship .The linear regression equations were y = 1 .0 × 107x-8728 .1 ,r = 1 .0000 and y = 3 .6 × 106x +6 . 1 × 105 ,r = 0 .9995 ,with the recovery rates being 100 .60% and 98 .33% respectively ,and RSD being 0 . 59% and 0 .52% ( n= 9) respectively .Conclusion The method is convenient and accurate can act as a qual-ity control method for the determination of caffeine and paracetamol in Compound Paracetamol and Chlor-phenamine through high performance liquid chromatography (HPLC) .%目的：探讨高效液相色谱法（HPLC）建立复方北豆根氨酚那敏片的质量控制方法。方法采用C18（4．6mm ×150mm ，5μm）色谱柱；流动相为甲醇（A）：水（B）＝25：75；检测波长：214nm ；柱温：25℃；流速：0．6ml/min ；进样量：10μl。结果咖啡因和对乙酰氨基酚分别在0．030～0．295μg、0．763～7．625μg范围内呈良好的线性关系，线性回归方程分别为：y ＝1．0×107x -8728．1，r ＝1．0000和 y ＝3．6×106x＋6．1×105，r ＝0．9995。回收率分别为100．60％和98．33％， RSD分别为0．59％和0．52％（ n ＝9）。结论该方法科学、简便、快速、准确，能同时对复方北豆根氨酚那敏片中咖啡因和对乙酰氨基酚两种成分有效地进行质量控制。
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