西北药学杂志2024,Vol.39Issue(4) :29-33.DOI:10.3969/j.issn.1004-2407.2024.04.006

UPLC法测定氨酚咖那敏片中3种主成分的含量

Content determination of the 3 major components in Paracetamol,Caffeine and Chlorphenamine Tablets by UPLC

陆璐璐 黄财顺 王素娟 赖昌威 王乾蕾
西北药学杂志2024,Vol.39Issue(4) :29-33.DOI:10.3969/j.issn.1004-2407.2024.04.006

UPLC法测定氨酚咖那敏片中3种主成分的含量

Content determination of the 3 major components in Paracetamol,Caffeine and Chlorphenamine Tablets by UPLC

陆璐璐 1黄财顺 1王素娟 1赖昌威 1王乾蕾1
扫码查看

作者信息

  • 1. 中山市食品药品检验所,中山 528437
  • 折叠

摘要

目的 建立超高效液相色谱法(ultra performance liquid chromatography,UPLC)测定氨酚咖那敏片中对乙酰氨基酚、咖啡因和马来酸氯苯那敏的含量.方法 用ACQUITY UPLC® HSS T3(100 mm×2.1 mm,1.8 μm)色谱柱,流动相为甲醇与含2 mL·L-1 三乙胺的冰醋酸水溶液(冰醋酸∶水=65∶1.5)(38∶62),等度洗脱.柱温为 35℃,流速为 0.2 mL·min-1,检测波长为262 nm.结果 对乙酰氨基酚、咖啡因和马来酸氯苯那敏的线性范围分别是100.37~401.47、6.66~33.28、6.55~45.82 μg·mL-1,相关系数均大于 0.999;稳定性和重复性实验的RSD值均小于 2.0%;氨酚咖那敏片中 3 个成分的平均回收率(n=9)分别为99.61%、103.95%、99.06%.结论 与现行药品执行标准中的含量测定方法比较,该文建立的UPLC法在氨酚咖那敏片的质量控制上更具优势.

Abstract

Objective To establish an ultra performance liquid chromatography(UPLC)method for the determination of paracetamol,caffeine and chlorphenamine maleate in Paracetamol,Caffeine and Chlorphenamine Tablets.Methods ACQUITY UPLC® HSS T3 column(100 mm×2.1 mm,1.8 μm)was used,and the mobile phase was methanol and glacial acetic acid containing 2 mL·L-1 triethylamine(glacial acetic acid∶water=65∶1.5)(38∶62).The column temperature was 35 ℃,and the flow rate was 0.2 mL·min-1.The detection wavelength was set at 262 nm.Results The linear ranges of acetaminophen,caffeine and chlorphenamine maleate were 100.37-401.47,6.66-33.28 and 6.55-45.82 μg·mL-1 respectively,and the correlation coefficients(r)were all bigger than 0.999.The RSDs of stability and repeatability tests were all less than 2.0%,and the average recoveries(n=9)of the 3 components were 99.61%,103.95%and 99.06%respectively.Conclusion The UPLC method established in this paper has more advantages in the quality control of Paracetamol,Caffeine and Chlorphenamine Tablet,compared with the current drug implementing standard.

关键词

超高效液相色谱法/氨酚咖那敏片/对乙酰氨基酚/咖啡因/马来酸氯苯那敏

Key words

UPLC/Paracetamol,Caffeine and Chlorphenamine Tablets/acetaminophen/caffeine/chlorphenamine maleate

引用本文复制引用

基金项目

广东省药品监督管理局2022年科技创新项目(2022TDB20)

出版年

2024
西北药学杂志
西安交通大学,陕西省药学会

西北药学杂志

CSTPCD
影响因子:0.912
ISSN:1004-2407
段落导航相关论文