HPLC法测定对乙酰氨基酚杂质含量

Determination of paracetamol impurity content by HPLC

提供了一种对乙酰氨基酚中对乙酰氨基酚二聚体杂质的高效液相检测方法,可以定量分析对乙酰氨基酚中该杂质的含量。检测方法为色谱柱:辛烷基硅烷键合硅胶色谱柱(250mm×4.6 mm,5μm);流动相:以磷酸盐缓冲液—甲醇(90∶10)为流动相;流速:1.0m L/min;柱温:40℃;进样量:20μl;检测波长:245 nm。该方法对乙酰氨基酚杂质线性关系良好,相对误差小于2%。HPLC法测定对乙酰氨基酚杂质含量操作简单,快速,准确,灵敏度高,为提高对乙酰氨基酚产品的质量提供了保障。

This paper provides a high-performance liquid phase detection method of acetaminophen dimer impurities in acetaminophen,which can quantitatively analyze the content of the impurity.The detection method is as follows chromatographic column:octane silane bonded silica gel chromatcolumn(250 mm 4.6 mm,5 m);flow phase:phosphate buffer-methanol(90∶10)as flow phase;flow rate:1.0 ml/min;column temperature:40℃;sample intake:20μl;detection wavelength:245 nm.The proposed method has a good linear relationship to the acetaminophen impurities,with a relative error of less than 2%.The determination of the impurity content by the HPLC method is simple,fast,accurate and highly sensitive to improve the quality of the acetaminophen products.