高效液相色谱法测定肺宝三效片中5种组分含量及均匀度

Determination of five components and content uniformity in Feibao Sanxiao tablets by HPLC

目的:建立高效液相色谱法测定肺宝三效片中马来酸氯苯那敏、咖啡因等5种组分的含量,考察马来酸氯苯那敏、盐酸麻黄碱、咖啡因的含量均匀度。方法:采用SinochromC_(18)色谱柱,甲醇-0.05 mol·L^(-1)磷酸二氢钾-三乙胺为流动相,检测波长为215 nm,流速1.0 mL·min^(-1),柱温42℃。结果:马来酸氯苯那敏的平均回收率为101.1％,RSD为0.7％(n=9);可豆碱的平均回收率为101.3％,RSD为2.1％(n=9);茶碱的平均回收率为100.4％,RSD为3.3％;盐酸麻黄碱的平均回收率为98.7％,RSD为5.4％;咖啡因的平均回收率为101.2％,RSD为2.3％。结论:方法简便,结果准确可靠,可用于本制剂质量控制的有效方法。

OBJECTIVE An HPLC method was established for determination of chlorphenamine maleate, theobromine, theo-phylline, ephedrine hydrochloride, caffeine and content uniformity was studied in Feibao Sanxiao tablets. METHODS A column of Sinochrom C18 was used and the mobile phase consisted of methanol-0.05 mol·L-1 KH2PO4-triethylamine and the flow rate was 1.0 mL·min-1. The UV detection wavelength was 215 nm and column temperature was 42℃. RESULTS The standard curve was linear of chlorphenamine maleate. The average recoveries of chlorphenanine maleate, theobromine, theophylline, ephedrine hydrochloride, caffeine were 101.1% with RSD 0.7% (n=9), 101.3% with RSD2.1% (n=9),100.4% with RSD 3.3% (n=9), 98.7% with RSD5.4% (rc=9) and 101.2% with RSD2.3% (n = 9) respectively. CONCLUSIONS The method is simple, accurate, useful in quality control for the tablets.