痛风颗粒HPLC指纹图谱研究

目的:建立痛风颗粒的高效液相色谱指纹图谱,为该制剂的质量控制提供依据。方法:色谱柱为ZORBAX SB-C1(8150mm×4.6mm,5μm),流动相为乙腈-0.05%磷酸水溶液(梯度洗脱),柱温为20℃,流速为1mL.min-1,进样量为10μL,检测波长为327nm。结果:10批痛风颗粒的指纹图谱中共有21个共有峰,以此21个峰为评价指标,方法测定的重复性、精密度、稳定性良好;10批制剂的相似度均大于0.9。结论:本方法准确、可靠,可以较全面、完整地反映痛风颗粒的质量。

Study on HPLC Fingerprint of Tongfeng Granules

OBJECTIVE：To establish HPLC fingerprint of Tongfeng granules,and to provide reference for the quality control of it.METHODS：The chromatography conditions consisted of ZORBAX SB-C18（150 mm×4.6 mm,5 μm） column with mobile phase of acetonitrile-0.05% phosphoric acid（gradient elution）;the column temperature was 20℃ with the flow rate of 1 mL·min-1;the injection volume was 10 μL;the UV detection wavelength was 327 nm.RESULTS：In this chromatography condition,21 common peaks were separated on HPLC fingerprints of 10 batches of Tongfeng granules and used as evaluation index.Each peak showed great repeatability,precision and stability among the sample.The similarity degree of 10 batches of samples was more than 0.9.CONCLUSION：The method is accurate,reliable,and can reflect complete information for the quality of Tongfeng granules.