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目的:建立反相高效液相色谱法同时测定茶碱麻黄碱胶囊中茶碱和盐酸麻黄碱含量的方法。方法:色谱柱为C_(18)柱(150 mm×4.6 mm,5μm),流动相为甲醇-0.06 mol·L~(-1)磷酸二氢钾溶液(用磷酸调节pH至2.5)(13:87),流速为0.8 ml·min~(-1),检测波长为210 nm,柱温35℃。结果:茶碱和盐酸麻黄碱浓度分别在18.4～183.8μg·ml~(-1)(r=0.999 8)和4.1～40.8μg·ml~(-1)(r=0.999 3)范围内与峰面积呈良好的线性关系,平均回收率分别为98.9%(RSD=1.1%)和97.6%(RSD= 1.2%)。结论:方法简便、准确、重复性好,可用于该制剂的质量控制。
Objective: To establish a method for the simultaneous determination of theophylline and ephedrine hydrochloride in theophylline ephedrine capsules by RP-HPLC. Method: The column was a C 18 column (150 mm×4.6 mm, 5 μm). The mobile phase was methanol-0.06 mol·L -1 potassium dihydrogen phosphate solution (pH was adjusted to 2.5 with phosphoric acid) (13: 87) The flow rate was 0.8 ml·min~(-1), the detection wavelength was 210 nm, and the column temperature was 35°C. Results: The concentrations of theophylline and ephedrine hydrochloride were in the range of 18.4 to 183.8 μg·ml -1 (r=0.999 8) and 4.1～40.8 μg·ml -1 (r=0.999 3), respectively. The area showed a good linear relationship with average recoveries of 98.9% (RSD=1.1%) and 97.6% (RSD=1.2%), respectively. Conclusion: The method is simple, accurate and reproducible. It can be used for the quality control of the preparation.