色谱法检测苍辛滴鼻液质量标准控制鉴别及含量分析

Quality Standard Research of Cangxin nasal drops

目的分析并建立苍辛滴鼻液的质量检测控制标准。方法采用TLC法对方中苍耳子、盐酸麻黄碱进行定性鉴别。用HPLC法测定方中盐酸麻黄碱含量,采用Shim-Pack CLC ODS柱(150×4.6mm,5μm),以乙睛-0.1%磷酸溶液(10∶90)为流动相,柱温25℃,流速为1.0ml/min,检测波长为207nm。结果薄层鉴别的色谱斑点清晰,特征斑点对应性强,阴性对照无干扰。盐酸麻黄碱在36.26μg/ml～181.30μg/ml范围内呈良好的线形关系(r=0.9996,n=5),平均回收率为98.89%,RSD 0.27%。结论本研究建立的TLC和HPLC法专属性强、灵敏度高、重现性好,可用于苍辛滴鼻液的质量控制。

Objective To establish the quality standard of Cangxin nasal drops.Methods The qualitative analysis of Fructus xanthil and Ephedrine hydrochloride were carried out by TLC;and the determination of Ephedrine hydrochloride in Cangxin nasal drops by HPLC.A Shim-Pack CLC ODS（150×4.6mm,5μm）column was used with acetonitrile-0.1% phosphate solution（10∶90） as mobile phases.The column temperature was 25℃.The flow rate was 1.0ml/min.The detection wavelength was at 207nm.Results The chromatographic spots of Fructus xanthil and Ephedrine hydrochloride were identified without the interference of negative control;The calibration curve was good linear relationship in the range of 36.26μg/ml^181.30μg/ml for Ephedrine hydrochloride（r=0.9996,n=5）.The average recovery was 98.89% and RSD was 0.27%.Conclusions The method we set up is of good specialization,high sensitivity and fine reproducibility,so,it can be used as quantity control for Cangxin nasal drops