HPLC法测定康乐鼻炎片中马来酸氯苯那敏的含量及含量均匀度  

HPLC method to determine the content and uniformity of chlorpheniramine maleate in Kangle Biyan tablets

作　　者：王海洋 王一博 杨献玲 翟宏宇 申玉华 WANG Haiyang;WANG Yibo;YANG Xianling;ZHAI Hongyu;SHEN Yuhua(Jilin Institute for Drug Control,Changchun 130033,China;Chengdu West China Clinical Research Center Co.,Ltd.,Chengdu 610041,China)

机构地区：[1]吉林省药品检验研究院,长春130033 [2]成都华西临床研究中心有限公司,成都610041

出　　处：《中国药品标准》2023年第4期428-431,共4页Drug Standards of China

摘　　要：目的:建立HPLC法测定康乐鼻炎片中马来酸氯苯那敏的含量及含量均匀度的方法。方法:采用Sepax C_(18)(4.6 mm×250 mm,5μm)色谱柱,甲醇-[水-三乙胺-磷酸(1000∶1∶1)](5∶95)为流动相,流速0.7 mL·min^(-1),柱温35℃,检测波长262 nm。结果:马来酸氯苯那敏在0.0848~2.1211μg(R=0.9998)范围内,线性关系良好,平均回收率为99.1%。收集的4家生产企业10批样品,测得马来酸氯苯那敏标示含量84.8%~98.9%,含量均匀度A+2.2S为6.9~18.5。结论:本方法简便、准确快速,专属性强,可用于康乐鼻炎片的质量控制。Objective:To establish an HPLC method for determining the content and uniformity of chlorpheniramine maleate in Kangle Biyan tablets.Methods:Sepax C_(18)(4.6 mm×250 mm,5μm)column was used,methanol-[water-triethylamine-phosphoric acid(1000∶1∶1)](5∶95)was used as the mobile phase,flow rate 0.7 mL·min^(-1),column temperature 35℃,detection wavelength 262 nm.Results:Chlorpheniramine maleate had a good linear relationship in the range of 0.0848-2.1211μg(R=0.9998),and the average recovery rate was 99.1%.The collected samples of 10 batches of 4 manufacturers showed that the labeled content of chlorpheniramine maleate were 84.8%-98.9%,and the content uniformity A+2.2S were 6.9-18.5.Conclusion:This method is simple,accurate and fast,and has strong exclusivity,which can be used for the quality control of the Kangle Biyan tablets.

关 键 词：康乐鼻炎片 马来酸氯苯那敏 含量 含量均匀度 

分 类 号：R921.2[医药卫生—药学]