摘要
目的:建立HPLC法测定小儿氨酚黄那敏片马来酸氯苯那敏含量及含量均匀度。方法:采用HPLC法,色谱柱:KromasilC18(250mm×4.6mm,5μm);流动相:乙腈-0.05mol/L磷酸氢二钠(含0.02%三乙胺,用磷酸调pH为3.5)(20:80);流速:1.0ml/min;检测波长:260nm。柱温:30℃。结果:马来酸氯苯那敏检测浓度的线性范围为0.811～8.12μg/ml(r=0.9996)。平均回收率为99.21%,RSD为0.25%。结论:方法灵敏,可靠,简单可行,可用于该制剂的马来酸氯苯那敏含量及含量均匀度测定。
Objective：To establish an HPLC method for determination of content and content uniformity chlorphenamine maleate inChildren Anfenhuangnamin Tablets.Methods：The Kromasil C18 column（250 mm×4.6 mm,5 μm） was used,acetonitrile-0.05 mol/L Na2HPO4（have 0.02% triethylamine,adjust pH to 3.5 by H3PO4）-（20：80） as the mobile phase.The detection wavelength was at 260 nm,the flow rate was 1.0 ml/min.The temperature of the column at 30℃.Results：the linear range was 0.811～8.12 μg/ml（r=0.999 6） for chlorphenamine maleate and the average recovery was 99.21% with RSD was 0.25%.Conclusion：The method is simple,reliable and sensitive.This method can be used for the determination of content and content uniformity of chlorphenamine maleate in Children Anfenhuangnamin Tablets.
出处
《中国当代医药》
2010年第30期28-29,共2页
China Modern Medicine
