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目的:建立小儿止咳合剂和止咳合剂中吗啡的含量测定方法。方法:采用固相萃取预处理结合HPLC测定,色谱条件为Agilent ZORBAX Eclipse XDB-C8色谱柱(4.6 mm×250 mm,5μm),流动相0.05 moL.L-1磷酸二氢钾溶液-0.002 5moL.L-1庚烷磺酸钠溶液-乙腈(18∶18∶5),检测波长220 nm。结果:吗啡在1.717～12.02 mg.L-1(r=0.999 8)与峰面积呈良好线性关系;小儿止咳合剂的平均回收率99.4%(RSD 2.01%),止咳合剂平均回收率100.9%(RSD 0.36%)。结论:该法简便、准确、重复性好,可作为该制剂的质量控制方法。
Objective: To establish a method for determination of morphine in children cough mixture and cough mixture. Methods: The chromatographic conditions were Agilent ZORBAX Eclipse XDB-C8 column (4.6 mm × 250 mm, 5 μm) and the mobile phase was 0.05 mol·L-1 potassium dihydrogen phosphate solution-0.002 5 molL by solid-phase extraction preconditioning combined with HPLC. L-1 heptane sulfonate solution - acetonitrile (18:18:5), detection wavelength of 220 nm. RESULTS: Morphine had a good linear relationship with peak area in the range of 1.717-12.02 mg · L-1 (r = 0.999 8). The average recovering rate of Xiaoer Zhike Mixture was 99.4% (RSD 2.01%) and the average recovery of cough mixture was 100.9% (RSD 0.36%). Conclusion: The method is simple, accurate and reproducible, and can be used as a quality control method for the preparation.