摘要
该文建立了高效液相色谱法(HPLC)测定硫酸阿托品注射液的含量,并对其进行系统的方法学验证.基于液相色谱分离原理,对硫酸阿托品注射液处方中的各个组分进行分离,在对药物主成分进行定量测定时辅料不会影响测定结果.对在该方法下,硫酸阿托品在0.0499~0.1496 mg·mL^(-1)浓度范围内线性良好,回收率在99.6%~100.0%(RSD=0.4%,n=9).该方法简单灵敏、重复性好、结果准确,适用于硫酸阿托品注射液的含量测定和质量控制.
In this study,a high-performance liquid chromatography(HPLC)method was established for the determination of atropine sulfate Injection content and its methodological validation.The chromatographic column used was SHISEIDO CAPCELL PAK C_(18)(4.6 mm×250 mm,5μm).The buffer solution consists of 0.013 mol·L^(-1)potassium dihydrogen phosphate and 0.014 mol·L^(-1)pentane sulfonic acid sodium(1.8 g potassium dihydrogen phosphate and 2.5 g pentane sulfonic acid sodium dissolved in 1 L water;pH adjusted to 2.5 with phosphoric acid).Mobile phase A was acetonitrile-buffer solution(5∶95),and mobile phase B was acetonitrile-buffer solution(80∶20)=75∶25.The flow rate was set at 1.0 mL·min^(-1),with detection wavelength at 210 nm,and column temperature at 30℃.Under this method,excipients did not interfere with the determination.atropine sulfate exhibited good linearity in the concentration range of 0.0499 to 0.1496 mg·mL^(-1),with a method linear correlation coefficient of r=1.000(n=5).The recovery rate ranged from 99.6%to 100.0%(RSD=0.4%,n=9).This method is simple,sensitive reproducible,and accurate,making it suitable for the determination and quality control of atropine sulfate injection.
作者
黄晓江
肖智心
祝丰啸
王一凡
朱婷
秦巨波
刘明星
HUANG Xiaojiang;XIAO Zhixin;ZHU Fengxiao;WANG Yifang;ZHU Ting;QIN Jubo;LIU Mingxing(School ofLife and Health Science,Hubei University of Technology,Wuhan 430068,China;Preparation Company of Grand Pharmaceutical(China)Co.,Ltd.,Wuhan 430040,China)
出处
《华中师范大学学报(自然科学版)》
北大核心
2025年第4期593-601,共9页
Journal of Central China Normal University:Natural Sciences
基金
国家自然科学基金项目(21401051).
关键词
硫酸阿托品
高效液相色谱
含量测定
质量标准
atropine sulfate
high performance liquid chromatography
content determination
standard of quality
