摘要
目的:用反相高效液相色谱方法测定阿咖酚散中对乙酰氨基酚、咖啡因、阿司匹林3种有效成分及相关杂质水杨酸的含量。方法:采用 Shim-pack CLC-ODS(150mm×6.0mm,5μm)色谱柱,流动相为甲醇-0.05mol·L^(-1)磷酸二氢钾(磷酸调pH=3.3)(43:57),检测波长为215nm,以非那西丁为内标物定量测定。结果:对乙酰氨基酚、咖啡因、阿司匹林、水杨酸分别在12.6～252μg·mL^(-1),3～60μg·mL^(-1),23～460μg·mL^(-1),4～80μg·mL^(-1)浓度范围内线性关系良好(r>0.9997),水杨酸的最小检出量为4ng。结论:用 HPLC 法测定阿咖酚散中3种主要成分及相关杂质的含量快速、准确。
Objective： An HPLC method was established for the determination of acetaminophen, caffeine, aspirin in Akafen powder, and its related impurity salicylic acid. Method： The chromatographic conditions were as follows ： Shim-pack CLC- ODS （150 mm ×6. 0 mm,5 μm） chromatographic column,methanol -0. 05 mol·L^-1 potassi- um dihydrogen phosphate solution（43：57 ）as mobile phase that the pH adjusted at 3.3 with phospheric acid. The flow rate of mobile phase was 1mL·min^-1. The detective wavelength was at 215 nm. Phenacetin was used as internal standard. Results： The linear relations were best （ r 〉 0. 9997 ） with the concentration range of four drugs in 12.6 -252 μg·mL^-1 ,3 -60 μg·mL^-1 ,23 -460 μg·mL^-1 and 4 -80μg·mL^-1 respectively. The mass detection limit of salicylic acid was 4ng. Conclusion：A specific, sensitive, simple and reproducible HPLC method was developed satisfactorily for the determination of the three substances and its related impurity salicylic acid.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2006年第5期692-695,共4页
Chinese Journal of Pharmaceutical Analysis
