对乙酰氨基酚缓释干混悬剂中对氨基酚限量的控制

Quantitative limitation of p-aminophenol 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中对氨基酚含量的方法。方法采用Hypersil C18(4.6mm×250mm,5μm)色谱柱;流动相:0.01mol.L-1戊烷磺酸钠甲醇溶液-甲酸-水(15:0.4:85);流速:1.0mL.min-1;检测波长为272nm;进样量20μL。结果对氨基酚浓度在2.0～20.0μg.mL-1范围内与峰面积呈良好的线性关系,r=0.9995。对氨基酚与对乙酰氨基酚能完全分离。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质量控制。

OBJECTIVE To develop a HPLC method for the quantitative limitation of p-aminophenol for paracetamol sustained release suspension. METHODS The chromatographic analysis was performed on Hypersil C18（5um, 4.6mm×250mm） column.The mobile phase consisted of 0.01mol· L^-1 sodium 1-pentanesulfonate in methanol-formic acid-water（15 ： 0.4 ： 85）, The flow rate was 1.0 mL·min^-1. The detection wavelength was at 272 nm, with injection volume 20uL. RESULTS A good linearity was obtained over the range of 2.0 -20.0ug·mL^-1 （r = 0. 9995）. CONCLUSION The method was simple, accurate, specific and could be used for the quality control of paracetamol sustained release suspension.