HPLC法测定感冒清热颗粒中欧前胡素含量

HPLC Determination of Imperatorin in Ganmao Qingre Granules and Quality Comparison

目的建立HPLC法测定感冒清热颗粒中欧前胡素含量的方法,同时对6家不同企业生产的产品进行质量比对。方法采用HPLC法欧前胡素含量测定条件:色谱柱:Diamonsil(R)C18(250 mm×4.6 mm,5μm),流动相:乙腈-水(49.5∶50.5),检测波长:300 nm,流速:1.0 ml·min-1。,柱温:35℃;葛根素含量测定方法参照《中国药典》。结果欧前胡素线性范围为0.2955～11.82μg·ml-1(r=0.9999),平均回收率为99.47%,RSD为0.69%(n=6);不同企业生产的产品质量有差异,葛根素的含量以每袋计为12.20～24.00 mg。结论 HPLC测定欧前胡素的方法简便,准确,重复性好,可有效控制该制剂的质量。

Objective To develop a method for content determination of imperatorin and to assess the quality of Ganmao Qingre granules produced in 6 different pharmaceutical factories ,via determination of puerarin. Methods The method of HPLC was employed. The analysis of imperatorin was carried out on Diamonsil （R） C18 （250 mm × 4.6 mm,5 μm） column with a mobile phase consisting of acetonitrile-water （49.5：50.5 ） at a flow rate of 1.0 ml ·min^-1. The detection wavelength was set at 300 nm and the column temperature was 35 ℃. Results A good linearity of imperatorin ranged from 0. 2955 to 11.82 μg ·min^-1 （ r = 0.9999 ） and the average recovery was 99.47% with RSD =0.69% （ n =6）. The content of puerarin ranged from 1.02 to 1.76 mg ·g^-1. There was obvi- ous difference in Ganmao Qingre granules between 6 different pharmaceutical factories. Conclusion This method is simple, accurate and highly reproducible. It can be used for quality control for Ganmao Qingre granules.