首页|UPLC法测定氨酚咖那敏片中3种主成分的含量

UPLC法测定氨酚咖那敏片中3种主成分的含量

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

UPLCParacetamol,Caffeine and Chlorphenamine Tabletsacetaminophencaffeinechlorphenamine maleate

陆璐璐、黄财顺、王素娟、赖昌威、王乾蕾

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中山市食品药品检验所,中山 528437

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

广东省药品监督管理局2022年科技创新项目

2022TDB20

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
年,卷(期):2024.39(4)