高效液相色谱法测定复方氨酚美沙糖浆中盐酸甲基麻黄碱、愈创甘油醚、氢溴酸右美沙芬的含量

摘要

Objective To establish a method for the quantitative determination of methylephedrine hydrochloride,guaifenesin and dex-tromethorphan hydrobromide in compound paracetamol and dextromethorphah syrup.Methods HPLC method was used and the separa-tion was performed on Agilent HC-C18 (4.6 mm ×250 mm,5 μm)column with gradient elution using methanol-0.1% phosphoric acid as mobile phase.The flow rate was 1 mL·min-1 and the detective wavelength was 216 nm.Results The linear ranges of methylephed-rine hydrochloride,guaifenesin and dextromethorphan hydrobromide were 0.141 2~1.412 μg (r=0.999 6),0.605 ~6.05 μg (r=0.999 8)and 0.156 8~1.568 μg (r=0.999 5)respectively.The average recoveries were 100.05%,98.69% and 99.68 % with RSD 2.24%,1.85% and 2.03%,respectively.Conclusions The method is rapid and accurate about determining methylephedrine hydrochloride,guaifenesin and dextromethorphan hydrobromide in compound paracetamol and dextromethorphah syrup.%目的：建立复方氨酚美沙糖浆中盐酸甲基麻黄碱、愈创甘油醚、氢溴酸右美沙芬的定量分析方法。方法采用HPLC法测定，色谱柱为Agilent HC-C18（4．6 mm ×250 mm，5μm）；流动相为甲醇-0．1％磷酸，梯度洗脱；流速为1 mL·min-1，检测波长为216 nm。结果盐酸甲基麻黄碱、愈创甘油醚、氢溴酸右美沙芬分别在0．1412～1．412、0．605～6．05、0．1568～1．568μg范围内线性关系良好（r分别为0．9996、0．9998、0．9995）；平均回收率分别为100．05％、98．69％、99．68％，RSD 分别为2．24％、1．85％、2．03％（n＝9）。结论该法快速准确，重复性好，可为复方氨酚美沙糖浆的质量控制提供定量评价方法。