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

作　　者：陆璐璐 黄财顺 王素娟 赖昌威 王乾蕾 LU Lulu;HUANG Caishun;WANG Sujuan;LAI Changwei;WANG Qianlei(Zhongshan Institute for Food and Drug Control,Zhongshan 528437,China)

机构地区：[1]中山市食品药品检验所,中山528437

出　　处：《西北药学杂志》2024年第4期29-33,共5页Northwest Pharmaceutical Journal

基　　金：广东省药品监督管理局2022年科技创新项目(编号:2022TDB20)。

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,1.8μm)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、6.55~45.82μg·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。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,1.8μm)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°C,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 6.55-45.82μg·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 

分 类 号：R927[医药卫生—药学]