HPLC测定小儿感冒丹中盐酸麻黄碱和盐酸伪麻黄碱的含量

Simultaneous Determination of Ephedrina Hydrochloridum and Pseudoephedrine Hydrochloride in Xiaoerganmaodan Patch by HPLC

目的:建立小儿感冒丹中盐酸麻黄碱和盐酸伪麻黄碱的含量测定方法。方法:用HPLC对小儿感冒丹中盐酸麻黄碱和盐酸伪麻黄碱进行定量分析。结果:盐酸麻黄碱的线性范围为0.120～0.600μg(r=0.999 9),平均加样回收率为100.80%,RSD 1.8%;盐酸伪麻黄碱的线性范围为0.148～0.740μg(r=0.999 8),平均加样回收率为99.12%,RSD 1.4%。结论:所建立的方法简便、准确、专属性强、可用于控制该制剂的质量。

Objective： This study is aimed to develop and validate a HPLC method for quantitative analysis of ephedrina hydrochloridum and pseudoephedrine hydrochloride in Xiaoerganmaodan Patch. Method： Phedrina hydrochloridum and pseudoephedrine hydrochloride were analyzed quantitatively by HPLC method. Result： A good linearity was obtained over the concentration range of 0.12-0.60 μg for ephedrina hydrochloridum （r=0.999 9）, and 0.148-0.740 μg for pseudoephedrine hydrochloride （r=0.999 8）.The average recovery of ephedrina hydrochloridum was 100.8%（RSD 1.8%）, and the average recovery of pseudoephedrine hydrochloride was 99.12%（RSD 1.4%）, respectively. Conclusion： The results of the study showed that the HPLC method was simple, sensitive and selective.It is suitable for the quality control of this preparation.