复方利巴韦林滴鼻剂中主药的含量测定

Determination method of basic remedy in Compound Ribavirin nose drops

目的建立复方利巴韦林滴鼻剂中主药的含量测定方法。方法以ZORBAX SB-CN(250mm×4.6mm,5μm)色谱柱,乙腈-水-磷酸(38∶62∶0.1)为流动相测定利巴韦林和盐酸苯海拉明的含量。检测波长为224nm,流速为1.0mL.m in-1。结果利巴韦林在0.1~1.0 mg.mL-1浓度范围有良好的线性关系,r=0.9990;平均回收率为100.3%,RSD=0.62%(n=9);盐酸苯海拉明回收率为100.8%,RSD=0.54%(n=9)。结论含量测定方法简单、准确和有效。

OBJECTIVE To establish a method for the determination of basic remedy in Compound Ribavirin nose drops.METHODS ZORBAX SB-CN(250mm×4.6mm,5μm) column was used to determine the content of Ribavirin and Diphenhydramine Hydrochloride,and the mobile phase of acetonitrile-water-phosphoric acid(38∶62∶0.1) was pumped at 1.0mL·min^(-1) through the column.The detector was set at 224nm. RESULTS A good linear relationship were obtained between the peak area and the concentration of Ribavirin from 0.1~1.0mg·mL^(-1)(r=0.9990),and the average recovery was 100.3%,the RSD was 0.62%(n=9);the average recovery of Diphenhydramine Hydrochloride was 100.8%,the RSD was 0.54%(n=9).CONCLUSION The method for determination is simple,accurate,and relable.