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目的:建立糖脉康颗粒的HPLC-DAD指纹图谱,为评价及控制药品质量提供可靠方法。方法:采用梯度洗脱方法对样品进行分析。DIKMA色谱柱(4.6 mm×250 mm,5μm),流动相0.4%冰乙酸-乙腈梯度洗脱,检测波长270 nm,柱温30℃;采用指纹图谱相似度软件进行数据分析。结果:建立了糖脉康颗粒的HPLC-DAD对照指纹图谱,方法精密度、稳定性和重复性良好。标示了21个共有色谱峰,14批样品的色谱指纹图谱的相似度>0.80。结论:糖脉康颗粒HPLC-DAD指纹图谱的建立,可为有效控制糖脉康颗粒成品制剂的质量提供参考。
Objective: To establish the HPLC-DAD fingerprint of Tangmaikang Granules and provide a reliable method for evaluating and controlling drug quality. Methods: Samples were analyzed by gradient elution. DIKMA column (4.6 mm×250 mm, 5 μm), mobile phase 0.4% glacial acetic acid-acetonitrile gradient, detection wavelength 270 nm, column temperature 30°C; fingerprint similarity software was used for data analysis. RESULTS: HPLC-DAD fingerprints of Tangmaikang Granule were established. The precision, stability and repeatability of the method were good. Twenty-one common chromatogram peaks were indicated, and the chromatographic fingerprints of the 14 batches had a similarity of >0.80. Conclusion: The establishment of HPLC-DAD fingerprint of Tangmaikang Granule can provide reference for the effective control of the quality of Tangmaikang Granules.