摘要
目的建立反相高效液相色谱法测定马来酸氯苯那敏注射液的含量。方法选用XterraRP18色谱柱(4.6mm×250mm,5μm),乙腈-0.02mol/L磷酸二氢钾(35︰65)为流动相,流速为1.0mL/min,检测波长为225nm,柱温30℃。结果马来酸氯苯那敏的浓度在13.16～105.28μg/mL范围内线性关系良好(r=0.9999,n=5),平均回收率为101.0%,RSD值为0.64%(n=6)。结论本方法操作简便、准确、重复性好,可用于马来酸氯苯那敏注射液的质量控制。
Objective To establish a reversed phase high-performance liquid chromatography method for the content determination of chlorpheniramine maleate（CM） in CM Injection.Methods The Xterra RP18 column（4.6 mm×250 mm,5μm） was used at a temperature of 30℃.The mobile phase consisted of acetonitrile-0.02 moL/L monopotassium phosphate（35︰65） at a flow rate of 1.0 mL/min,and the determination wavelength was 225 nm.Results The concentration of CM displayed a good linear relationship from 13.16 to 105.28 μg/mL（r = 0.999 9,n = 5）.The average recovery rate was 101.0%,and the relative standard deviation was 0.64%（n = 6）.Conclusion The method is simple,accurate and repeatable,which can be used for quality control of CM injection.
出处
《中国当代医药》
2012年第36期66-67,78,共3页
China Modern Medicine
关键词
马来酸氯苯那敏注射液
反相高效液相色谱法
含量测定
质量控制
Chlorpheniramine maleate injection
Reversed phase high-performance liquid chromatography
Content determination
Quality control
