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目的:建立复方降糖滴丸的HPLC指纹图谱,为科学评价及有效控制制剂的质量提供有效可靠的方法。方法:采用HPLC梯度洗脱方法对样品进行分离分析,色谱柱:BDS C18(4.6 mm×250 mm,5μm),流动相水-乙腈梯度洗脱,检测波长238 nm,柱温30℃。结果:10批样品得到的色谱指纹图谱有5个共有峰,相似度均在0.99以上。方法精密度、稳定性和重复性良好。结论:本方法为复方降糖滴丸的质量评价提供了依据。
OBJECTIVE: To establish an HPLC fingerprinting of compound hypoglycemic dripping pills, which can provide an effective and reliable method for scientific evaluation and effective control of the quality of preparation. Methods: HPLC gradient elution was used to separate and analyze the samples. The chromatographic column was BDS C18 (4.6 mm × 250 mm, 5 μm). The mobile phase consisted of water and acetonitrile. The detection wavelength was 238 nm and the column temperature was 30 ℃. Results: The chromatographic fingerprints obtained from 10 batches of samples had 5 common peaks with similarities of more than 0.99. The method has good precision, stability and repeatability. Conclusion: This method provides the basis for the quality evaluation of compound hypoglycemic dripping pills.