HPLC梯度洗脱法测定对乙酰氨基酚口服混悬液中有关物质

摘要

目的：采用高效液相色谱法（HPLC）梯度洗脱测定对乙酰氨基酚口服混悬液中有关物质含量。方法：用Inertsustain C18（250mm×4.6mm，5μm）为色谱柱；以0.05mol·L-1醋酸铵溶液和甲醇为流动相进行梯度洗脱；检测波长为245nm，流速为1.0mL·min-1，柱温为25℃。结果：各峰间能完全分离；对乙酰氨基酚和对氨基酚的最低检测浓度分别为0.027μg·mL-1和0.093μg·mL-1；对乙酰氨基酚在0.037～0.33μg·mL-1范围内峰面积与浓度呈良好的线性关系，对氨基酚在0.26～3.09μg·mL-1范围内峰面积与浓度呈良好的线性关系；中间精密度试验对氨基酚RSD为13.77%。结论：该方法专属性好、灵敏、结果准确，可用于对乙酰氨基酚口服混悬液的有关物质含量控制。%Objective:To established an HPLC method for the determination of related substances in paracetamol oral suspension. Methods:A Inertsustain C18 column (250mm ×4.6mm,5μm)was adopted.The mobile phase of gradient elution was ammonium acetate solution of 0.05mol·L-1 and methanol.The wavelength of detector was 245nm,the flow rate was 1.0mL·min-1,the Column temperature was 25℃.Results:Any two peaks was completely separated.The detected limit were 0.027μg·mL-1and 0.093μg·mL-1 for paracetamol and 4-aminophenol.The calibration curve was l inear in the range of 0.037~0.33μg·mL-1 and 0.26~3.09μg·mL-1.the RSD was 13.77%(n=12) for 4-aminophenol.Conclusion:The proposed HPLC method could be used for the determination of reltated substances in paracetamol oral suspension.