摘要
目的建立对乙酰氨基酚软胶囊有关物质的高效液相色谱测定方法。方法采用Agilent XDB-C18(150 mm×4.6 mm,5μm)色谱柱,甲醇-水-磷酸(20∶80∶0.1)为流动相,流速1.0 mL.min-1,检测波长为272 nm。结果对氨基酚最低检出限为1.25 ng.mL-1,对乙酰氨基酚与对氨基酚及其他有关物质达到基线分离。结论本方法简便、准确、专属性高,可用于本制剂的有关物质控制。
Objective To establish an HPLC method for the determination of related substances for Paracetamol Soft Capsules.Methods The chromatographic analysis was performed on Agilent XDB-C18（150 mm×4.6 mm,5 μm）column.The mobile phase was methanol-water-phosphoric acid（20∶80∶0.1）.The flow rate was 1.0 mL·min-1.The detection wavelength was 272 nm.Results The lowest detection limit of p-aminophenol was 1.25 ng·mL-1（S/N=3）.P-aminophenol and its related substances were well isolated with paracetamol.Conclusion The method was simple,accurate,specific and can be used for the quality control of the preparation.
出处
《齐鲁药事》
2011年第7期394-396,共3页
qilu pharmaceutical affairs
