HPLC测定复方锌布颗粒中马来酸氯苯那敏含量

目的：建立复方锌布颗粒中马来酸氯苯那敏含量的HPLC测定方法.方法：采用高效液相色谱法,色谱柱为Water RP18色谱柱（250mm×4.6mm,5μm）,流动相为乙腈：0.3％十二烷基硫酸钠溶液：磷酸（60：40：0.02）（用三乙胺调pH值至3.3±0,1）,流速为1.0mL/min,柱温：35℃,检测波长为224nm.结果：平均回收率为99.7％,相对标准偏差（RSD）为1.2％,马来酸氯苯那敏的线性范围为2.016～100.8μg/mL,系统精密度为0.6％.结论：用HPLC测定复方锌布颗粒中马来酸氯苯那敏的含量可以用于复方锌布颗粒的质量控制.

Assay of Maleate Chlorpheniramine in Zinc Compound Coth Particles by HPLC

Objective：To create a zinc compound cloth particles maleate, chlorpheniramine by HPLC. Methods： HPLC. The chro- matographic column is Water RP18 column （250 min×4.6mm, 5 μm） ; the mobile phase is Acetonitrile-0.3% sodium dodecyl sul- fate solution- the phosphate （60：40：0.02） （adjusted with triethylamine pH value to 3.3±0.1） while the flow rate is 1.0mL/min with column temperature 35℃ at wavelength 224 nm. Results：The Average Recovery Rate is 99.7% ; the Relative Standard Devia- tion （RSD） is 1.2% ; the linear range of the maleate chlorpheniramine is 2. 016 - 100.8 μg/mL, and the system accuracy is 0.6%. Conclusion ： It is available to control the quality of the compound zinc cloth particles by applying HPLC to determine the content of the maleate chlorpheniramine.