HPLC法测定小儿氨酚黄那敏片中对乙酰氨基酚和马来酸氯苯那敏的含量

目的：建立HPLC法同时测定小儿氨酚黄那敏片中对乙酰氨基酚和马来酸氯苯那敏含量。方法：采用HypersilC18（150mm×4．6mm，5μm）色谱柱，甲醇-0．05mol·L^-1磷酸二氢钾溶液-三乙胺（10：90：0．02）（用磷酸调pH=3．4）为流动相，检测波长为216nm，柱温为30℃，流速为1．0ml·min^-1，进样量为20μl。结果：对乙酰氨基酚、马来酸氯苯那敏分别在40．08-240．48μg·ml^-1（r=0．9992）和0．37～2．21μg·ml^-1（r=0．9971）浓度范围内呈现出良好的线性关系；方法平均回收率分别为99．75％和98．95％；RSD分别为0．23％和0．36％。结论：该方法简便、快速，两组分分离度好，其他成分无干扰，测定结果准确可靠，可作为该制剂质量控制的有效方法。

Determination of Paracetamol and Chlorphenamine Maleate in Children Anfenhuangnamin Tablets by HPLC

Objective： To establish an HPLC method for the determination of paracetamol and chlorphenamine mateate in children Anfenhuangnamin tablets. Method： The hypersil C18 column （150mm×4.6mm,5 μm）was used. The mobile phase consisted of methanol-0. 05 mol. L^-1 potassium dihydrogen phosphate-triethy lamine （ 10 ： 90 ： 0.02 ） （ pH were adjusted to 3.4 with diluted phosphate acid）. The UV detection wavelength was 261nm. The flow rate was 1.0 ml· min^-1 with the column temperatureat was 30℃. External standard method was used. Result： The linear ranges were 40.08 - 240.48 μg· ml ^-1 for paracetamol and 0.37 - 2.21 μg·ml ^-1 for chlorphenmnine mateate. The average recoveries were 99.75% and 98.95% with RSD 0. 23% , 0.36% （ r = 0. 999 2 ,r =0.997 1 ） respectively. Conclusion： The proposed method appeared to be simple, rapid, sensitive and accurate. It is available to the quality control of children Anfenhuangnamin tablets.