苯海拉明麻黄碱滴鼻液的质量标准研究

Quality Standard for Diphenhydramine and Ephedrine Nasal Drops

目的建立苯海拉明麻黄碱滴鼻液的质量控制方法。方法采用HPLC法测定滴鼻液中盐酸苯海拉明和盐酸麻黄碱的含量;色谱条件：色谱柱以氰基键合硅胶为填充剂;流动相为乙腈-水-三乙胺（50∶50∶0.5）（用冰醋酸调节pH值至6.5）;流速1 ml·min^-1;检测波长258 nm。结果化学反应和HPLC能检出盐酸苯海拉明和盐酸麻黄碱。在上述色谱条件下,盐酸苯海拉明和盐酸麻黄碱获得良好分离;进样浓度分别在0.0499~0.3996 mg·ml^-1（r=0.9999,n=5）,0.2000~1.6002 mg·ml^-1（r=0.9999,n=5）范围内与峰面积呈良好的线性关系。盐酸苯海拉明平均回收率为100.0%,RSD为0.4%（n=9）。盐酸麻黄碱平均回收率为99.68%,RSD为0.4%（n=9）。结论本方法准确,重复性好,可作为苯海拉明麻黄碱滴鼻液的质量控制方法。

Objective To establish a method for quality control of Diphenhydramine and Ephedrine Nasal Drops. Methods The chromatographic conditions included the CN column （200 mm × 4.6 mm ,5 μm） and acetonitrile- water-triethylamine （50： 50： 0.5）（the pH was adjusted to 6.5 with glacial acetic acid） as the mobile phase ,The flow rate was 1.0 ml -min - 1 and monitored at 258 nm. Results Diphenhydramine hydroehloride and ephedrine hydroehlo- ride were identified by chemical reaction methods and HPLC. They were well separated. The calibration curve of di- phenhydramine hydrochloride and ephedrine hydroehloride was linear in the range of 0.0499 - 0. 3996 mg .ml^-1 （ r = 0. 9999, n =5）and 0.2000-1. 6002 mg .ml^-1（ r = 0.9999, n = 5 ）. The average recovery was 100.0% with an RSD of 0.4% （ n = 9） and 99.68% with an RSD of 0.4% （ n = 9） respectively. Conclusion This method is accu- rate and reproducible. It can be used as a reliable method for quality control of Diphenhydramine and Ephedrine Nasal Drops.