双波长HPLC法同时测定复方水杨酸甲酯软膏中盐酸麻黄碱和水杨酸甲酯的含量

发布时间：2018-04-11 08:30

本文选题：复方水杨酸甲酯软膏 + 盐酸麻黄碱　；参考：《中国药房》2015年03期

【摘要】：目的:建立同时测定复方水杨酸甲酯软膏中盐酸麻黄碱和水杨酸甲酯含量的方法。方法:采用高效液相色谱法。色谱柱为Agilent ZORBAX SB-C18,流动相为乙腈-磷酸三乙胺溶液(梯度洗脱),流速为1.0 ml/min,进样量为20μl,柱温为室温,盐酸麻黄碱的检测波长为207 nm,水杨酸甲酯的检测波长为304 nm。结果:盐酸麻黄碱、水杨酸甲酯质量浓度分别在5.0~150.0、0.014 16~0.424 8μg/ml范围内与各自峰面积积分值呈良好线性关系(r=0.999 9、0.999 8);精密度、稳定性、重复性试验的RSD≤1.36%;平均加样回收率分别为99.31%、100.00%,RSD分别为0.99%、1.12%(n=3)。结论:该方法操作简便、准确、重复性好,可用于复方水杨酸甲酯软膏的质量控制。
[Abstract]:Objective: to establish a method for simultaneous determination of ephedrine hydrochloride and methyl salicylate in compound methyl salicylate ointment.Methods: high performance liquid chromatography was used.The chromatographic column was Agilent ZORBAX SB-C18, the mobile phase was acetonitrile-triethylamine phosphate (gradient elution), the flow rate was 1.0 ml / min, the injection volume was 20 渭 l, the column temperature was room temperature, the detection wavelength of ephedrine hydrochloride was 207 nm, and the detection wavelength of methyl salicylate was 304 nm.Results: the concentration of ephedrine hydrochloride and methyl salicylate in the range of 5. 0 0. 0. 0. 0. 014 0. 014 and 0. 424 8 渭 g/ml showed a good linear relationship with their respective peak area integral values.The RSD of reproducibility test was less than 1.36, and the average recoveries were 99.31 and 100.000.The average recoveries were 0.99 and 1.12, respectively.Conclusion: the method is simple, accurate and reproducible, and can be used for the quality control of compound methyl salicylate ointment.
【作者单位】：首都医科大学附属北京世纪坛医院药剂科;北京市食品药品监督管理局;
【基金】：首都卫生发展科研专项项目——“医院制剂注册标准研究”(No.首发2011-2008-01)
【分类号】：R927.2;O657.72

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