论文部分内容阅读
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。
Objective: To establish a method for simultaneous determination of ephedrine hydrochloride and methyl salicylate in compound methyl salicylate ointment. Methods: Using high performance liquid chromatography. The column was Agilent ZORBAX SB-C18. The mobile phase consisted of acetonitrile-triethylamine phosphate buffer (gradient elution) at a flow rate of 1.0 ml / min. The injection volume was 20 μl and the column temperature was room temperature. The detection wavelength of ephedrine hydrochloride was 207 nm, the detection wavelength of methyl salicylate is 304 nm. Results: The concentrations of ephedrine hydrochloride and methyl salicylate showed a good linear relationship (r = 0.999 9,0.999 8) with the integral values of their peak areas in the range of 5.0-150.0 and 0.014 16-0.424 8μg / ml respectively. The precision , RSD≤1.36% for stability and repeatability test. The average recoveries were 99.31% and 100.00%, respectively. The RSDs were 0.99% and 1.12% (n = 3) respectively. Conclusion: The method is simple, accurate, reproducible and can be used for quality control of compound methyl salicylate ointment.