张火旺
ZHANG Huo-wang (Heyuan Institute for Drug Control

• 1:河源市药品检验所 广东河源517000

摘要(Abstract)：

目的建立用HPLC同时测定小儿氨酚黄那敏颗粒中对乙酰氨基酚和马来酸氯苯那敏含量的方法。方法采用Hy-persil C18(150 mm×4.6 mm,5μm)色谱柱,甲醇—0.05 mol/L磷酸二氢钾溶液—三乙胺(10∶90∶0.02)(用磷酸调pH为3.4)为流动相,检测波长为216 nm,柱温:30℃。流速为1.0 m l/m in,进样量为20μl。结果对乙酰氨基酚;马来酸氯苯那敏线性范围分别在40.13~240.77μg/m l与0.37~2.19μg/m l;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100.24%与99.73%。RSD分别为0.4%与0.7%。结论该方法简便,快速,二组分分离度好,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。
Objective To establish an HPLC method for the defermination of Paracetamol and Chlorphenamine Mateate in Xiao'er Anfen Huang Namin Granules.Method The Hypersil C_(18) column(150 mm×4.6 mm,5 μm)was used.The mobile phase consisted of methanol-0.05 mol/L Potassium dihydrogen Phosphate-triethy lamine(10∶90∶0.02)(pH were adjusted to 3.4 with diluted phosphate acid).The UV detection wavelength was 261 nm.The flow rate was 1.0 ml/min with the column temperatureat 30 ℃.External standard method was used.Result The linear ranges were 40.13～280.77 μg/ml for Paracetamol and 0.37～2.19 μg/ml for Chlorphenamine Mateate.The Average Recoveries were 100.24% and 99.73% with RSD 0.4%,0.7%.respectively.Conclusion The proposed method appeared to be simple,rapid,sensitive and accurste.It is available to the quality control of Xiao'er Anfen Huang Namin Granules.

关键词(KeyWords)： 小儿氨酚黄那敏颗粒;对乙酰氨基酚;马来酸氯苯那敏;HPLC
Xiao'er Anfen Huang Namin Granules;paracetamol;chlorphenamine maleate;HPLC

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基金项目(Foundation):

作者(Author): 张火旺
ZHANG Huo-wang (Heyuan Institute for Drug Control

参考文献(References)：

• [1]国家药品监督管理局国家药品标准(试行).W S—10001—(HD—0214)[S].