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目的:建立对羟基苯乙酮含量测定的方法,为清肝利胆口服液的质量控制提供依据。方法:采用高效液相色谱法测定对羟基苯乙酮的含量,Kromasil 100-5 C18色谱柱(4.6 mm×250 mm,5μm),流动相甲醇-0.1%磷酸溶液(25∶75),流速1.0 mL·min-1,检测波长275 nm,进样量10μL,柱温35℃。结果:对羟基苯乙酮在0.213～5.335μg线性关系良好(r=0.999 9),平均加样回收率101.86%(RSD 0.38%)。3批样品中对羟基苯乙酮含量分别为0.22,0.19,0.18 mg/支。结论:方法专属性强、简便、准确、稳定,可用于清肝利胆口服液的质量控制。
OBJECTIVE: To establish a method for the determination of hydroxyacetophenone and provide the basis for the quality control of Qingganliyin oral liquid. Methods: The content of p - hydroxyacetophenone was determined by high performance liquid chromatography (Kromasil 100-5 C18 column 4.6 mm × 250 mm, 5 μm), mobile phase methanol - 0.1% phosphoric acid solution mL · min-1, detection wavelength 275 nm, injection volume 10μL, column temperature 35 ℃. Results: The linear calibration curve of p - hydroxyacetophenone was 0.213 ~ 5.335μg (r = 0.999 9). The average recoveries were 101.86% (RSD 0.38%). Three batches of samples of hydroxyacetophenone were 0.22,0.19,0.18 mg / support. Conclusion: The method is specific, simple, accurate and stable, and can be used for quality control of Qinggan Liguan oral liquid.