HPLC法测定利巴韦林滴眼液中抑菌剂的含量  

Determination of bacteriostatic agents of ribavirin eye drops by HPLC

作　　者：李立理 徐可 张菁 刘云 李慧 LI Lili;XU Ke;ZHANG Jing;LIU Yun;LI Hui(Shijiazhuang Institute for Food and Drug Control,Shijiazhuang 050031,China;Hebei Provincial Institute for Drug Control,Shijiazhuang 050011,China)

机构地区：[1]石家庄市食品药品检验中心,石家庄050031 [2]河北省药品检验研究院,石家庄050011

出　　处：《中国药品标准》2020年第5期424-428,共5页Drug Standards of China

摘　　要：目的:建立利巴韦林滴眼液中抑菌剂(羟苯乙酯、硫柳汞、苯扎溴铵)含量的测定方法。方法:采用HPLC法,Agilent HC-C 18(2)色谱柱(4.6 mm×250 mm,5μm),以1%三乙胺溶液(磷酸调pH值至3.0)为流动相A,以甲醇为流动相B,梯度洗脱,检测波长214 nm,柱温为30℃,进样量:20μL。结果:抑菌剂在各自的线性范围内,线性关系良好(r>0.9999),平均回收率在99.2%~99.8%范围内,RSD均小于2.0%(n=9)。按拟定方法测定样品中羟苯乙酯含量为0.25~0.29 mg·mL-1,苯扎溴铵含量为0.083~0.086 mg·mL-1,硫柳汞含量为0.010 mg·mL-1。结论:该方法灵敏、快速,专属性强,可准确测定滴眼剂中不同抑菌剂的含量。Objective:To establish a method for content determination of bacteriostatic agents(ethylparaben,thiomersal and benzalkonium bromide)in ribavirin eye drops.Method:The test was performed in Agilent HC-C 18(2)column(4.6 mm×250 mm,5μm)under the gradient elution of mobile phase A of 0.1%triethylamine solution(adjust pH to 3.0 by phosphoric acid)and mobile phase B of methanol.The detection wavelength was 214 nm,injection volume was 20μL and column temperature was 30℃.Results:The bacteriostatic agents all had a good linear relationship in the respective ranges c with r>0.9999.The average recoveries were 99.2%-99.8%with RSDs less than 2.0%(n=9).The test results of samples showed that the contents of ethylparaben were 0.25-0.29 mg·mL-1,the content of benzalkonium bromide were 0.083-0.086 mg·mL-1,and the content of thiomersal was 0.010 mg·mL-1.Conclusion:The established method is sensitive,rapid and specific,and it can be used for determination of different bacteriostatic agents in ribavirin eye drops.

关 键 词：利巴韦林滴眼液 抑菌剂 含量测定 梯度洗脱 高效液相色谱法 

分 类 号：R921.2[医药卫生—药学]