高效液相色谱法测定复方茶碱甲麻黄碱片中组分含量的研究

HPLC Studies on Quantitative Determination of Ingredients in Compound Theophylline and Methyiephedrine Tablets

目的:采用高效液相色谱法考察并建立了同时测定复方茶碱甲麻黄碱片中茶碱及甲麻黄碱的含量。方法:Kromasil C_(18)(200 mm×4.6 mm,5 μm)柱,乙腈-1%三乙胺的水溶液(20:80)用冰醋酸调pH至7.5为流动相,流速为0.7 mL·min^(-1),UV检测波长215 nm,柱温为室温(约20℃)。结果:茶碱、甲麻黄碱浓度在20—100μg·mL^(-1),100—500μg·mL^(-1)范围内与峰面积呈良好的线性关系,r分别为0.9997,0.9996。平均回收率依次为100.8%,99.7%。结论:本方法简便快捷,结果准确可靠,可用于该复方制剂的含量测定等相关研究。

Objective;To establish an exteral standard HPLC method for the simultaneous quantitative determination of Theophylline and Methylephedrine in Compound Theophylline and Methylephedrine Tablets. Methods: The chromatographic conditions were as follows;Kromasil C_(18)(200 mm×4. 6 mm,5 μm),the mobile phase:acetonitrile-1% triethylamine in water(20: 80), adjusted to pH 7. 5 with glacial acetic acid, the flow rate was 0. 7 mL·min^(-1) and UV detection wavelength was at 215 nm, column temperature was room temperature (approximate 20℃). Results:The calibration curves were linear in the range of 20-100μg·mL^(-1) for Theophylline(r=0. 9997),100-500 μg·mL^(-1) for Methylephedrine(r=0. 9996). The average recovery was 100.8% and 99.7% respectively. Conclusion: The method is accurate and reliable for the quality control of this compound preparation.