HPLC法测定康乐鼻炎片中马来酸氯苯那敏的含量

Determination of the Content of Chlorpheniramine Maleate in KangleBiyan Tablets by HPLC

目的建立康乐鼻炎片中马来酸氯苯那敏的含量测定方法。方法色谱柱Thermo C1(8250mm×4.6mm,5μm),用乙腈-甲醇-水-冰醋酸(35︰35︰30︰0.5)(含十二烷基硫酸钠0.35%)为流动相,流速为1.0ml/min,检测波长为260nm。结果本方法的线性范围10.3～76.9μg/ml(r=0.9999),平均回收率为97.6%,RSD为2.5%。结论本方法可用于控制康乐鼻炎片中马来酸氯苯那敏的含量。

Objective To establish a method for the determination of the content of Chlorpheniramine Maleate in Kangle Biyan tablets. Methods The Thermo C18 column （250 mm×4.6 mm, 5 um ） was used, the acetonitrile-methanol-water-glacial acetic acid （35□35□30□0.5）（Sodium dodecyl sulfate 0.35%） was used as mobile phase, the flow rate was 1.0 ml/min, and the detection wavelength was 260 nm. Results The linear range of the method was 10.3-76.9 ug/ml （r=0.9999）, the average recovery, was 97.6%, with RSD 2.5%. Conclusion It can be used for the quality control of the Kangle Biyan tablets.