HPLC法同时测定小儿麻甘颗粒中盐酸麻黄碱及盐酸伪麻黄碱含量

Determination of Ephedrine Hydrochloride and Pseudoephedrine Hydrochloride Contents in Xiao’er Magan Granule by HPLC

目的建立小儿麻甘颗粒中盐酸麻黄碱及盐酸伪麻黄碱含量测定方法,为其质量控制提供参考。方法色谱柱为Phenyl-Ether极性乙醚连接苯基键合硅胶柱(4.6mm×250mm),流动相为甲醇-0.092%磷酸溶液(含0.04%三乙胺和0.02%二正丁胺)(1.5∶98.5),检测波长为210nm。结果盐酸麻黄碱在0.9875~19.7504 g/mL 范围内线性关系良好(R2=1),平均回收率为 100.0%,RSD 为 0.65%(n=6);盐酸伪麻黄碱在 0.9893~19.7852 g/mL范围内线性关系良好(R2=1),平均回收率为99.01%,RSD为0.84%(n=6)。结论该方法准确可靠,可用于小儿麻甘颗粒的质量控制。

Objective To establish a method of determing ephedrine hydrochloride and pseudoephedrine hydrochloride contents in Xiao’er Magan granule by high performance liquid chromatography (HPLC). Methods The chromatographic column was Phenyl-Ether polar ether-linked phenyl-bonded silica gel column (4.6 mm×250 mm),the mobile phase was methanol-0.092% phosphoric acid solution (containing 0.04% triethylamine and 0.02% dibutylamine)(1.5∶98.5),and the detection wavelength was 210nm. Results The linearity of ephedrine hydrochloride was good in the range of 0.9875~19.7504 ug/mL (R2=1),the average recovery was 100.0%,RSD was 0.65%(n=6);the linearity of pseudoephedrine hydrochloride was good in the range of 0.9893~19.7852 ug/mL (R2=1),the average recovery was 99.01%,RSD was 0.84%(n=6). Conclusion The methods of HPLC is simply,reliable and repeatable,offering a reliable basis to determine the ephedrine hydrochloride and pseudoephedrine hy- drochloride contents in Xiao’er Magan granule.