HPLC法测定对乙酰氨基酚缓释干混悬剂的有关物质

Determination of p-aminophenol and its related substances for paracetamol sustained release suspension by HPLC

目的建立高效液相色谱法测定对乙酰氨基酚缓释干混悬剂的对氨基酚及有关物质的方法。方法采用Diamonsil C18(4.6mm×150mm,5μm)色谱柱;流动相:甲醇-水(20∶80);流速:1.0mL·min-1;检测波长为275nm;进样量10μL。结果方法的最低检测限浓度为0.03μg.mL-1,对氨基酚及有关物质与主峰达到基线分离。结论本方法简便、准确、专属性强,可用于对乙酰氨基酚缓释干混悬剂的对氨基酚及有关物质的测定。

OBJECTIVE To develop HPLC method for the determination of p-aminophenol and its related substances for paracetamol sustained release suspension.METHODS The chromatographic analysis was performed on Diamonsil C18（4.6 mm×250 mm,5μm）column.The mobile phase consisted of Methanol-Water（20∶80）.The flow rate was 1.0mL·min-1.The detection wavelength was at 275nm,with injection volume 10μL.RESULTS The lowest limit determination was 0.03μg·mL-1（S/N=3）.P-aminophenol and its related substances were well isolated with paracetamol.CONCLUSION The method was simple,accurate,specific and will be used for the quality control of p-aminophenol and its related substances for paracetamol sustained release suspension.