HPLC法测定对乙酰氨基酚口服溶液中的有关物质对氨基酚

HPLC determination of related substances in paracetamol oral solution

目的:采用高效液相色谱(HPLC)法测定对乙酰氨基酚口服溶液中的有关物质的含量。方法:用Inertsil ODS-3色谱柱(250 mm×4.6 mm,5μm),以甲醇-0.01 mol·L-1丁烷磺酸钠溶液-甲酸(15∶85∶0.4)为流动相,检测波长272 nm,流速1.0mL·min-1。结果:主成分与对氨基酚能完全分离,对氨基酚在0.527～5.27μg·mL-1浓度范围内峰面积与浓度呈良好的线性关系,最低检出限约为0.5 ng;重复性试验RSD为7.0%;平均回收率为98.3%,RSD为5.1%。结论:该方法专属性好,操作简便,快速准确,可用于乙酰氨基酚口服溶液中的有关物质对氨基酚的含量测定。

Objective：To established an HPLC method for the determination of related substances in paracetamol oral solution.Methods：A Inertsil ODS-3 column（250 mm×4.6 mm,5 μm） was adopted.The mobile phase was methanol and 0.01 mol·L-1 sodium 1-butanesulfonate and formic acid（15∶85∶0.4）.The wavelength of detector was 272 nm,the flow rate was 1.0 mL·min-1.Results：Paracetamol was completely separated from 4-Aminophenol.The calibration curve was 1inear in the range of 0.527-5.27 μg·mL-1 and the correlation coefficient was 0.9998,the detected limit was 0.5 ng,the RSD of reproducibility was 7.0%（n=6）,the average recovery was 98.3%,and the RSD was 5.1%（n=9）.Conclusion：The proposed HPLC method could be used for the determination of reltated substances in paracetamol oral solution.