高效液相色谱法测定感冒滴鼻剂中利巴韦林和盐酸苯海拉明的含量

Content Determination of Ribavirin and Diphenhydramine Hydrochloride in Flu Nasal Drops by HPLC

目的：建立以高效液相色谱法测定感冒滴鼻剂中利巴韦林和盐酸苯海拉明含量的方法。方法：色谱柱为Zorbax SB—CN，流动相为乙腈-水-磷酸（38：62：0．1），检测波长为224nm，流速为1．0ml／min，进样量为20p1。结果：利巴韦林、盐酸苯海拉明检测浓度分别在0．1～1．0mg／ml（r=0．9990）、0．02～0．2mg／ml（r=0．9990）范围内与峰面积积分值呈良好的线性关系，平均回收率分别为100．3％（RSD=0．62％，n=9）、100．8％（RSD=0．54％，n=9）。结论：本方法简便、快速、准确、回收率好，可用于该制剂的质量控制。

OBJECTIVE： To establish a HPLC method for content determination of ribavirin and diphenhydramine hydrochloride in flu nasal drops.METHODS： The chromato bar was ZORBAX SB-CN, the mobile phase was acetonitrile-water-phosphoric acid（38 ： 62 ： 0.1）, with the flow rate of 1.0ml/ min and the detection wave at 224nm, the sample size was 20/.1 .RESULTS：A good linear relationship were obtained between the peak areas and the concentrations of ribavirin and diphenhydramine hydrochloride respectively in the range from 0.1-1.0mg/ml（ r = 0.9 990） and 0.02-0.2mg/ml（ r = 0.9 930）, the average recoveries were 100.3 % （ RSD = 0.62 %, n = 9） and 100.8 % （ RSD = 0.54 %, n = 9）, respectively. CONCLUSION： This method is convenient, rapid, accurate, and brings about good recovery, it can be used for quality control of flu nasal drops.