HPLC同时测定酚麻美敏片中的4种成分

Simultaneous determination of four components in Fenmameimin tablets by HPLC

目的采用HPLC法测定酚麻美敏片中对乙酰氨基酚、盐酸伪麻黄碱、氢溴酸右美沙芬、马来酸氯苯那敏等4种成分的含量。方法采用双波长法;色谱柱为Kromasil C18柱,流动相为甲醇-磷酸盐缓冲液（38∶62）,流速为1.0 m L·min^-1,DAD检测器,检测波长为309（对乙酰氨基酚）、266（其他3个成分）nm,柱温为35℃。结果 4种成分在所选波长处均能达到基线分离,各成分在线性范围内与峰面积呈良好的线性关系,加样回收率为98.6%～101.1%。结论所用方法简便、准确,可用于酚麻美敏片的含量测定。

OBJECTIVE To establish an HPLC method for the simultaneous determination of paracetamol,pseudoephedrine hydrochloride,dextromethorphan hydrobromide and chlorphenamine maleate in Fenmameimin tablets. METHODS The two different detecting wavelengths were simultaneously used for HPLC analyses of paracetamol（ 266 nm） and the other three components（ 309 nm）. The chromatographic separation was achieved on a C18 culumn. The mobile phase were methanol- phosphate buffer（ 38∶62） with the flow rate of 1. 0 m L·min^- 1 and the column temperature of 35 ℃. RESULTS The four effective components were separated well and showed good linearity. The average recoveries were between 98. 6%- 101. 1%. CONCLUSION The method can be successfully used for the quality control of Fenmameimin tablets.