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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 establish a HPLC method for the determination of imperatorin in cold and heat-clearing granules, and to compare the quality of the products produced by 6 different enterprises. Methods HPLC was used to determine the content of imperatorin. The chromatographic conditions were as follows: Diamonsil (R) C18 (250 mm × 4.6 mm, 5 μm), mobile phase of acetonitrile- water (49.5:50.5), detection wavelength of 300 nm, 1.0 ml · min-1. , Column temperature: 35 ℃; puerarin content determination method with reference to “Chinese Pharmacopoeia.” Results The linear range of Imperatorin was 0.2955 ~ 11.82μg · ml-1 (r = 0.9999) with the average recovery of 99.47% and the RSD of 0.69% (n = 6). The quality of the products produced by different enterprises was different. The content of each bag is 12.20 ~ 24.00 mg. Conclusion The method for the determination of imperatorin by HPLC is simple, accurate and reproducible. It can effectively control the quality of the preparation.