高效液相色谱法同时测定复方乙酰水杨酸片中各有效成分的含量

摘要

The present research is to establish a HPLC method for the determination of aspirin, phenacetin and caffeine in compound aspirin tablets. In this method, a Kromasil C18 column (4. 6 mmX 250 mm, 5 μm) was used and the mobile phase was methanol-1% acetic acid solution (45 : 55) with the flow rate of 1. 0 Ml ? Min-1. The UV detection wavelength was 276 nm and the column temperature was 35 °C. The injection volume was 20 Μl and external standard method was adopted. The calibration curves were linear in the range of 4 - 960 μg/Ml(R2 =0. 999 9)for aspirin, 4-200 /μg/Ml (R2 = 0. 999 9) for phenacetin, and 4 ~ 200 /μg/Ml (R2 = 0. 999 9) for caffeine. The average recoveries are 99.2%, 100.4%, 101.1% for the three components respectively with RSD of 1. 2%, 1. 4%, 0. 9%. The method is simple, sensitive, accurate, and can be applied applicable to the analysis of compound aspirin tablets.%用高效液相色谱法分离并建立了复方乙酰水杨酸片中阿司匹林、非那西丁和咖啡因含量的测定方法.色谱分析条件分别为:色谱柱为Kromasil C18(4.6mm×250 mm,5 μm),柱温为35℃；流动相为甲醇-1％冰醋酸(45∶55),流速为1.0 mL/min.检测波长为276 nm.进样量为20 μL,外标法定量.在该色谱条件下,阿司匹林、非那西丁及咖啡因分离度均大于1.5,且浓度与峰面积呈良好的线性关系,线性范围分别为4～960 μg/mL(R2 =0.999 9)、4～200 μg/mL(R2=0.9999)及4～200μg/mL(R2=0.999 9),平均加标回收率分别为99.2％(RSD=1.2％)、100.4％(RSD=1.4％)及101.1％ (RSD=0.9％).所建立的方法简单、灵敏、准确,可用于复方乙酰水杨酸片的质量控制.