反相离子对梯度洗脱色谱法测定甲麻芩苷那敏片中3组分含量

Determination of 3 components in methylephedrine hydrochloride,baicalin and chlorphenamine maleate tablets by RP-ion-pair chromatography

目的：建立测定甲麻芩苷那敏片中3组分（盐酸甲基麻黄碱、黄芩苷和马来酸氯苯那敏）含量的反相离子对HPLC法。方法：采用色谱柱Inertsil ODS-3（250mm×4.6mm，5μm，柱温30℃），以[0．2％辛烷磺酸钠溶液-三乙胺（100：0.2，磷酸调节pH至4.3）]．甲醇（50：50）为流动相A，以甲醇为流动相B，流动相B的比例由1％-98％匀速递增进行洗脱；检测波长为215nm：流速为1.0mL/min。结果：盐酸甲基麻黄碱、黄芩苷及马来酸氯苯那敏的线性范围分别为0．5～25μg（r=0.9998），0.3～17／μg（r=1.000）和0.01，0.5μg（r=1.000），平均回收率分别为100.3％（RSD=1.3％）、99.9％（RSD=1.1％）和99.6％（RSD=1.2％）。结论：本文建立的方法简单、迅速，可用于甲麻芩苷那敏片中3组分的含量测定。

Aim：To establish an ion-pair RP-HPLC method to determine 3 components in methylephedrine hydrochloride, baicalin and chlorphenamine maleate tablets. Methods： The column was Inertsil ODS-3 column （250 mm × 4.6 mm, 5μm）. [ 0.2 % Sodium octanestdfonate-triethylamine （ 100：0.2, pH 4.3, adjust with phosphoric acid） l-methanol （50：50）was used as the mobile phase A and methanol as mobile phase B with the flow rate of 1.0 mL/min, and gradi- ent was 1% - 98% in 30 min. The detection wavelength was 215 nm. Results：The linear range for methylephedrine hydrochloride, baicalin and chlorphenamine maleate were 0.5 - 25 μg （ r = 0.999 8 ）, 0.3 - 17 μg （ r = 1.000） and 0.01 - 0.5 μg （ r = 1.000）, respectively. The average recoveries were 100.3 % （ RSD = 1.3 % ） for methylephedrine hydrochloride, 99.9 % （RSD = 1.1% ） for baicalin and 99.6 % （RSD = 1.2 % ） for chlorphenamine maleate, respectively. Conclusion： The method is simple, quick and reliable. It can be used to determine the content of 3 components in methylephedrine hydrochloride, baicalin and chlorphenamine maleate tablets.