HPLC法测定苯海拉明麻黄素滴鼻液中盐酸苯海拉明含量

Determination of Diphenhydramine Hydrochloride in Diphenhydramine and Ephedrine Nasal Drops by HPLC

目的:建立高效液相色谱法(HPLC)测定苯海拉明麻黄素滴鼻液中盐酸苯海拉明的含量。方法:采用Agilent SB-Aq(250mm×4.6mm,5μm)色谱柱,流动相为甲醇-乙腈-1%十二烷基硫酸钠溶液(29∶35∶36)(冰醋酸调pH=3.4),流速为1.0mL/min,柱温为30℃;检测波长为258nm。结果:盐酸苯海拉明在1.002~15.030μg进样量范围内与其峰面积积分线性关系良好(r=0.999 9),平均回收率为101.1%,RSD为0.46%(n=9)。结论:该法简便、准确、重复性好,可作为苯海拉明麻黄素滴鼻液的质量控制方法。

Objective：To establish a HPLC method for the determination of diphenhydramine hydrochloride in Diphenhydramine and Ephedrine Nasal Drops.Methods：Agilent SB-Aq column（4.6 mm×250 mm,5μm）was used.The mobile phase was consisting of methanol-acetonitrile-1% sodium laury lsulfate solution（29∶35∶36）（pH was adjusted to 3.4 with acetic acid glacial）with a flow rate of 1.0 mL/min.The column temperature was set at 30℃.The detection wavelength was 258 nm.Results：There was a good linear relation（r = 0.999 8）between peak area and the contents of diphenhydramine hydrochloride in the range of 1.002-15.030μg（r=0.999 9）.The average recovery was 101.1% with RSD of 0.46%（n =9）.Conclusion：The methods are simple,accurate and repeatable,which are the effective methods for the quality control of Diphenhydramine and Ephedrine Nasal Drops.