HPLC法测定复方氨酚苯海拉明片中盐酸麻黄碱和盐酸苯海拉明的含量

目的建立HPLC法测定复方氨酚苯海拉明片中盐酸麻黄碱和盐酸苯海拉明的含量。方法用Kromasil C18(250 mm×4.6 mm,5μm)色谱柱;流动相甲醇-乙腈-1%十二烷基硫酸钠溶液(26∶32∶42)(冰醋酸调pH值3.1),检测波长257 nm。结果线性范围,盐酸麻黄碱:1.228 8~11.059 2μg,r=0.999 9,盐酸苯海拉明:1.216 8~10.951 2μg,r=1.000 0;平均回收率,盐酸麻黄碱98.79%,RSD%=0.59%,盐酸苯海拉明100.44%,RSD%=0.57%。结论本方法简便、准确、灵敏度高、重现性好,可更好地控制本品的质量。

Content Determination of Ephedrine Hydrochloride and Diphenhydramine Hydrochloride in Compound Anfenbenbenhailaming Tablets by HPLC

Objective To establish a method for the determination of ephedrine hydrochloride and diphenhydramine hydrochloride in compound Anfenbenbenhailaming tablets by high performance liquid chromatography(HPLC).Methods Kromasil C18(250 mm×4.6 mm,5 μm) column was used and the mobile phase was methanol-acetonitrile-1% sodium laurylsulfate solution(26:32:42)(pH was adjusted to 4.5 with acetic acid glacial).The detection wavelength was 257 nm.Results The linear range was as follows: that of ephedrine hydrochloride was 1.228 8-11.059 2 μg(r=0.999 9),and that of diphenhydramine hydrochloride was 1.216 8-10.951 2 μg(r=1.000 0).The recovery rate of ephedrine hydrochloride was 98.79%(RSD%=0.59%),and that diphenhydramine hydrochloride was 100.44%(RSD%=0.57%).Conclusion The method of HPLC is simple,accurate,highly sensitive and reproducible,and can provide a reference standard for the quality control of Ankahuangmin tablets or capsules.