摘要
目的:建立高效液相色谱法测定消旋山莨菪碱滴眼液中苯扎溴铵的含量。方法:色谱柱:Waters SunFire^(TM)C18柱(4.6 mm×250 mm,5μm);流动相:乙腈-三乙胺磷酸溶液(取三乙胺4 mL和磷酸7 mL,加水稀释至1 000 mL)(60∶40);流速1 mL·min^(-1);检测波长215 nm。结果:苯扎溴铵的浓度在0.013 6～0.109 0 mg·mL^(-1)范围内与色谱峰面积呈现良好的线性关系,(r=0.999 9),平均回收率为99.4%,RSD=0.3%。结论:本法测定消旋山莨菪碱滴眼液中抑菌剂苯扎溴铵,具有简便、准确、重现性好的优点。
Objective: To establish a method for the determination of benzalkonium bromide in raceanisodamine eye drops by HPLC. Methods:The chromatographic column was Waters SunFireTM C18 column(4.6 mm×250 mm, 5 μm). The mobile phase was ace-triethylaminephosphoric acid solution(4 mL of triethylamine and 7 mL of phosphoric acid diluted to 1 000 mL with water)(60∶40). Flow rate was 1 mL·min^-1 and detection wavelength was 215 nm. Results:The concentration of benzalkonium bromide in the range of 0.013 62-0.109 0 mg·mL^-1showed a good linear relationship with the chromatographic peak area(r=0.099 99), with an average recovery rate of 99.4% and RSD of 0.3%. Conclusion: This method was simple,accurate and highly repeatable for the determination of benzalkonium bromide in raceanisodamine eye drops.
作者
吴珺
钱忠义
WU Jun;QIAN Zhongyi(Taizhou Institute for Food and Drug Contral, Taizhou, 225300, China)
出处
《中国药品标准》
CAS
2019年第2期160-163,共4页
Drug Standards of China
