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目的建立同时测定对乙酰氨基酚和乙酰水杨酸二组分含量的HPLC测定方法。方法色 谱条件为:采用Kromasil C18(250 mm×4．6 mm,5 μm)色谱柱,V(甲醇):V(水):V(冰醋酸)=26:71:3为 流动相,流速1．5mL／min,检测波长280nm。结果乙酰水杨酸的线性范围是62．91-143．02μg／mL, 平均回收率为102．30％,RSD为1．3％;对乙酰氨基酚的线性范围是20．31-91．89μg／mL,平均回收率 为103．21％,RSD为1．5％。结论本方法简便,可用于小儿退烧片中乙酰水杨酸和对乙酰氨基酚含量的同 时测定,结果可以满足对该制剂质量控制的要求。
Objective To establish a HPLC method for the simultaneous determination of acetaminophen and acetylsalicylic acid in two components. Methods Chromatographic conditions were as follows: Kromasil C18 (250 mm × 4.6 mm, 5 μm) column, V (methanol): V .5mL / min, detection wavelength 280nm. Results The linear range of acetylsalicylic acid was 62.91-143.02μg / mL with the average recovery of 102.30% and RSD of 1.3%. The linear range of acetaminophen was 20.31-91.89μg / ML, the average recovery was 103.21%, RSD was 1.5%. Conclusions This method is simple and can be used for the simultaneous determination of acetylsalicylic acid and acetaminophen in Xiao’er Fuzao Tablets. The results meet the requirements of quality control of this preparation.