HPLC法测定氯芬黄敏片中马来酸氯苯那敏含量均匀度

Determination of uniformity of chlorpheniramine maleate in compound diclofenac sodium chlorphenamine maleate tablets by HPLC

目的用HPLC法测定氯芬黄敏片中马来酸氯苯那敏含量。方法使用C18硅烷键合硅胶柱(150nm×4.6mm),检测波长262nm,用庚烷磺酸钠溶液:甲醇-乙腈(30:18)45:55为流动相。结果马来酸氯苯那敏在0.01686～0.08516mg/L范围内线性关系良好。方法的平均回收率分别为100.7%和98.8%(n=9)。结论该方法简便、准确、重复性好,可用于氯芬黄敏片中马来酸氯苯那敏含量均匀度的测定。

Objective Determination of uniformity of chlorpheniramine maleate in compound diclofenae sodium ehlorphenamine maleate tablets by HPLC. Methods ODS-C18 column （ 150 nm ×4. 6 mm） was used, the detection wavelength at 262 nm, Heptane tanesulfonic acid Sodium solution：methanol： acetonitrile （30：18） 45：55 as mobile phase. Results The calibration carver was linear in the range of 0. 016 86-0. 085 16 mg/L for chlorphenamine maleate. The average recovery was 100. 7% and 98. 8% respectively. Conclusions The method is simple, accurate, and well rep rodueible. It can be used for determination of uniformity of ehlorphenamine maleate in compound dielofenaesodium ehlorphenamine maleate tablets.