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目的:建立HPLC法同时测定小儿氨酚黄那敏片中对乙酰氨基酚和马来酸氯苯那敏含量。方法:采用Hypersil C_(18) (150mm×4.6mm,5μm)色谱柱,甲醇-0.05mol·L~(-1)磷酸二氢钾溶液-三乙胺(10:90:0.02)(用磷酸调pH=3.4)为流动相,检测波长为216nm,柱温为30℃,流速为1.0ml·min~(-1),进样量为20μl。结果:对乙酰氨基酚、马来酸氯苯那敏分别在40.08～240.48μg·ml~(-1)(r=0.999 2)和0.37～2.21μg·ml~(-1)(r=0.997 1)浓度范围内呈现出良好的线性关系;方法平均回收率分别为99.75%和98.95%;RSD分别为0.23%和0.36%。结论:该方法简便、快速,两组分分离度好,其他成分无干扰,测定结果准确可靠,可作为该制剂质量控制的有效方法。
Objective: To establish a HPLC method for the simultaneous determination of paracetamol and chlorphenamine maleate in pediatric aminophenanthroline tablets. Methods: Hypersil C18 (150 mm × 4.6 mm, 5 μm) column, methanol-0.05 mol·L -1 potassium dihydrogen phosphate solution-triethylamine (10: 90: 0.02) pH = 3.4) as the mobile phase. The detection wavelength was 216nm, the column temperature was 30 ℃, the flow rate was 1.0ml · min -1, and the injection volume was 20μl. Results: Paracetamol and chlorpheniramine maleate were respectively detected in 40.08 ~ 240.48μg · ml -1 (r = 0.999 2) and 0.37 ~ 2.21μg · ml -1 (r = 0.997 1 ) Showed a good linear relationship within the concentration range; the average recoveries of the method were 99.75% and 98.95%, respectively; the RSDs were 0.23% and 0.36% respectively. Conclusion: The method is simple and rapid, the separation of the two components is good, the other components have no interference and the determination results are accurate and reliable, which can be used as an effective method for the quality control of the preparation.