HPLC测定咳特灵胶囊中马来酸氯苯那敏的含量及均匀度

Content Uniformity Determination of Chlorphenamine Maleate in Keteling Capsules by HPLC

目的：建立咳特灵胶囊中马来酸氯苯那敏的高效液相色谱分析方法。方法：C18柱，乙腈-0.3%十二烷基硫酸钠溶液-磷酸（60∶40∶0.02）（用三乙胺调节pH值至3.3±0.1）为流动相，流速为1.0 mL·min-1；于225 nm测定咳特灵胶囊中的马来酸氯苯那敏含量。结果：马来酸氯苯那敏的线性范围为156.08～936.48 μg，平均回收率为98.23%（RSD=0.12%）。结论：该方法简便、准确、无干扰，可用于咳特灵胶囊中马来酸氯苯那敏的含量及含量均匀度的测定。

Objective： To establish HPLC method for content uniformity determination of chlorphenamine maleate in Keteling Capsules. Methods： C18 column was used, the mobile phase is acetonitrile-0. 3% SDS-phosphoric acid （60：40：0. 02, adapt pH to 3.3 with triethylamine）, the flow rate is 1.0 mL·min^-1, detecting wavelength is 225 nm. Results： The linear range of chlorphenamine maleate was 156. 08 - 936. 48μg. The average recovery was 98.23% with RSD 0. 12%. Conclusion： The method is simple, sensitive, rapid and accurate, can be used for the quality control of Keteling Capsules.