高珊,唐蕾,赵伟国
GAO Shan,TANG Lei,ZHAO Weiguo

• 1:中山大学附属中山医院

摘要(Abstract)：

目的采用高效液相色谱法同时测定苯麻滴鼻液中盐酸麻黄碱和盐酸苯海拉明的含量。方法采用Eclipse XDB-C18柱(250 mm×4.6 mm,5μm),以甲醇-0.05 mol/L磷酸二氢钾水溶液(用85%磷酸溶液调节p H3.0)-三乙胺(52∶48∶0.2)为流动相,流速为1 m L/min,柱温为30℃,检测波长为257 nm。结果盐酸麻黄碱与盐酸苯海拉明的线性范围分别为2.025 8~6.077 4 mg/m L(r=0.999 9)和0.201 4~0.604 2 mg/m L(r=0.999 9),平均回收率分别为99.96%(RSD=0.43%)和100.14%(RSD=0.58%)。结论本研究所建立的含量测定方法操作简便,重复性好,适用于苯麻滴鼻液的质量控制。
OBJECTIVE To establish a method for simultaneous content determination of ephedrine hydrochloride and diphenhydramine hydrochloride in the nasal drops by HPLC. METHODS The chromatographic conditions included the Eclipse XDBC18column( 250 mm×4. 6 mm,5 μm) and methanol-0.05 mol / L potassium dihydrogen phosphate( the p H was adjusted 3.0 with 85%phosphoric acid)-trimethylamine( 52 ∶ 48 ∶ 0. 2) as the mobile phase. The flow rate was 1. 0 m L / min and monitored at 257 nm.RESULTS The concentration of ephedrine hydrochloride in 2.025 8-6.077 4 mg / m L was linear. The average recovery and RSD were99.96% and 0.43%,respectively( n = 9). The linear range of diphenhydramine hydrochloride was 0.201 4-0.604 2 mg / m L. The average recovery rate was 100.14% with RSD 0. 58%( n = 9). CONCLUSION This method is fast and reproducible. It can be used as a reliable method for quality control of Diphenhydramine and Ephedrine Nasal drops.

关键词(KeyWords)： 高效液相色谱法;苯麻滴鼻液;盐酸苯海拉明;盐酸麻黄碱
HPLC;Diphenhydramine and Ephedrine Nasal drops;Diphenhydramine hydrochloride;Ephedrine Hydrochloride

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基金项目(Foundation):

作者(Author): 高珊,唐蕾,赵伟国
GAO Shan,TANG Lei,ZHAO Weiguo

参考文献(References)：

• [1]张钢平,余卫兵,毕雪艳,等.HPLC法测定复方苯海拉明滴鼻剂的含量[J].中国药事,2008,22(3):241-243.
• [2]张涛.HPLC法测定复方苯海拉明麻黄碱麻黄碱、苯海拉明的含量[J].中国医药导报,2009,6(21):42-44.
• [3]朱旭江,常琦,贺军权,等.HPLC法同时测定复方苯海拉明麻黄碱糖浆三组分的含量[J].中国药事,2009,23(3):275-278.