HPLC法测定羚黄氨咖敏片中马来酸氯苯那敏的含量

Chlorphenamine Maleate Content Measurement in Linghuangankamin Tablet by HPLC Method

建立HPLC法测定羚黄氨咖敏片中马来酸氯苯那敏含量的分析方法。采用KromasilC18(150mm×4.6mm,5μm)色谱柱;以0.3%十二烷基硫酸钠溶液(取十二烷基硫酸钠,加水500mL,加磷酸0.25mL,用三乙胺调节pH值3.3±0.1)-乙腈(55∶45)为流动相;流速1.0mL/min;检测波长261nm;柱温:室温,进样量:20μL。马来酸氯苯那敏浓度在2.5～75μg/mL范围内呈良好的线性关系,(r=0.9999,n=6)。高、中、低3种浓度的平均回收率为100.15%。RSD平均值为0.77%(n=9)。HPLC法简便、准确,专属性强,灵敏度高,可有效控制羚黄氨咖敏片中马来酸氯苯那敏的含量。

In order to establish a method to test and measure the content of chlorphenamine maleate in linghuangankamin tablet （a tablet compound of antelope horn, artificial bezoar, paraeetamol, caffeine, and ehlorphenamine maleate） by HPLC method, analysis with Kromasil C18 column （150 mm × 4.6 ram, 5 μm） was adopted with mobile phase of 0.3% sodium laurylsulfate （6.8g sodium laurylsufate plus 0.25 mL phosphoric acid and water to 500 mL, and adjust pH to 3.3 ±0.1 with triethylamine） at flowing rate of 1.0 mL/min and detecting wave length at 261 nm under room temperature. The sample was injected at 20 μL. The results showed that the linear ranges of ehlorphenamine maleate were 10 - 120 μg/mL （ r = 0. 999 9, n = 6 ）. The average recovery was 100.15% for three different levels with RSD =0.77% （n =9）. Therefore, this method was convenient, accurate, specific, and sensitive, and it can be used for the quality control of chlorphenamine maleate in linghuangankamin tablet.