HPLC法测定小儿清热止咳口服液中盐酸麻黄碱、盐酸伪麻黄碱和苦杏仁苷的含量

Content Determination of Ephedrine Hydrochloride, Pseudoephedrine Hydrochloride and Amygdalin in Xiao’er Qingre Zhike Oral Solution by HPLC

目的:建立同时测定小儿清热止咳口服液中盐酸麻黄碱、盐酸伪麻黄碱和苦杏仁苷含量的方法。方法:采用高效液相色谱法。色谱柱为Platisil ODS柱,流动相为乙腈-0.1%磷酸溶液(含0.1%三乙胺)=5∶95,流速为1.0mL·min-1,检测波长为215nm,进样量为10μL,柱温为30℃。结果:盐酸麻黄碱进样量在0.146～4.85μg范围内与峰面积积分值呈良好的线性关系(r=0.9999),平均加样回收率为99.4%,RSD=1.0%;盐酸伪麻黄碱进样量在0.157～5.23μg范围内与峰面积积分值呈良好的线性关系(r=0.9999),平均加样回收率为99.6%,RSD=1.7%;苦杏仁苷进样量在0.297～9.90μg范围内与峰面积积分值呈良好线性关系(r=0.9999),平均加样回收率为98.9%,RSD=0.7%。结论:该方法简便、灵敏、准确,可用于小儿清热止咳口服液的质量控制。

OBJECTIVE： To establish the method for the content determination of ephedrine hydrochloride, pseudoephedrine hydrochloride and amygdalin in Xiao’er qingre zhike oral solution. METHODS： HPLC method was adopted. The determination was performed on Platisil ODS column with mobile phase consisted of acetonitrile-0.1%phosphoric acid solution （containing 0.1% triethylamine, 5 ∶ 95） at the flow rate of 1.0 mL·min^-1. The detection wavelength was set at 215 nm and injection volume was 10 μL. The column temperature was 30 ℃. RESULTS： The linear range of ephedrine hydrochloride was 0.146～4.85 μg （r=0.999 9） with an average recovery of 99.4% （RSD=1.0%）. The linear range of pseudoephedrine hydrochloride was 0.157～5.23 μg （r=0.999 9） with an average recovery of 99.6% （RSD=1.7%）. The linear range of amygdalin was 0.297～9.90 μg （r=0.999 9） with an average recovery of 98.9% （RSD=0.7%） . CONCLUSION： The method is simple, sensitive and accurate, which can be used for the quality control of Xiao’er qingre zhike oral solution.