关键词: font-size:medium, ">氨酚麻美干混悬剂；高效液相色谱法；有关物质；对氨基酚；抗坏血酸

Abstract: Objective： To establish a HPLC method to determine the content of the relative substance of 4-aminophenol in paracetamol， pseadoephedrine hydrochloride and dextromethorphan hydrobromide for suspension，to provide scientific basis for quality control of paracetamol， pseadoephedrine hydrochloride and dextromethorphan hydrobromide for suspension. Methods： The Agilent Zorbax SB-C18 (4.6 mm×250 mm， 5 μm) column was adopted with the mobile phase of 0.05 mol·L-1 ammonium acetate-methanol (88∶12) at the flow rate of 1.0 mL·min-1. The temperature of column was 30 ℃ and the detection wavelength was 231 nm and a mixture containing 10 mg·L-1 ascorbic acid was used as solvent. Results： The linear relationship of 4-aminophenol was good in the range of 0.048 06-4.806 μg·mL-1， r=1.000 (n=6). The limit of detection was 0.07 ng and the average recovery was 98.4%. The RSD was 1.3% (n=9). Test solutions were stable in 24 h and not required to prepare immediately before use. Conclusion： The method is simple， accurate， sensitive and with good specificity， which can be used for content determination of 4-aminophenol in this product.

Key words: Paracetamol, pseadoephedrine hydrochloride and dextromethorphan hydrobromide for suspension； HPLC； Related substances； 4-aminophenol； Ascorbic acid