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

Simultaneous Determination of Ephedrine Hydrochloride and Methyl Salicylate in Compound Methyl Salicylate Ointment by Dual Wave-length HPLC

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 the method for simultaneous determination of ephedrine hydrochloride and methyl salicy- late in Compound methyl salicylate ointment. METHODS： HPLC method was adopted. The determination was performed on Agi- lent ZORBAX SB-C^8 column with mobile phase composed of acetonitrile-triethylamine phosphate solution （gradient elution） at the flow rate of 1.0 ml/min. The sample size was 20 μl. The column temperature was room temperature. The detection wavelength was set at 207 nm for ephedrine hydrochloride and 304 nm for methyl salicylate, respectively. RESULTS ： The linear range of ephedrine hydrochloride was 5.0-150.0 μg/ml （r=0.999 9） with an average recovery of 99.31% （RSD=-0.99% ,n-=3）. The linear range of methyl salicylate was 0.014 16-0.424 8 mg/ml （r=0.999 8） with an average recovery rate of 100.00% （RSD=1.12% ,n=3）. RSDs of precision, stability and reproducibility tests were ≤ 1.36 %. CONCLUSIONS： The method is simple, accurate and reproducible, and can be used for the quality control of Compound methyl salicylate ointment.