摘要
目的:建立一种用HPLC法,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Shim-pack VP-ODS(150mm×4.6mm 5μm)色谱柱,甲醇-水-冰醋酸(40:60:0.5)为流动相,检测波长为261nm,柱温:40℃.结果:对乙酰氨基酚;马来酸氯苯那敏线性范围分别在40～280μg·ml-1 0.32～2.24μg·ml-1;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:99.40%,98.95%.相关系数r=0.9999,r=0.9997 RSD为0.55% 1.43%.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 determination of Paracetamol and Chlorphenamine Maleate in Xiao'er Anfen Huang Namin Granules.Methods:The Shim-pack VP-ODS(150mm×4.6mm,5μm)was used.The mobile phase consisted of methanol-water-acetic acid(40∶60∶0.5).The UV detection wavelength was 261nm.The flow rate was 1.0ml·min -1 with the column temperature at 40℃.External standard method was used.Results:The linear ranges were 40～280μg·ml -1 for Paracetamol and 0.32～2.24μg·ml -1 for Chlorphenamine Maleate.The average recoveries were 99.40% and 98.95% with RSD 0.55% and 1.43%,respectively.Conclusion:The proposed method appeared to be simple,rapid,senstive and accurate.It is available to the quality control of Xiao'er Anfen Huang Namin Granules.
出处
《中国药品标准》
CAS
2005年第3期75-77,共3页
Drug Standards of China
