复尔康注射液挥发性和非挥发性成分HPLC特征图谱

HPLC specific chromatogram of volatile constituents and involatile in Fuerkang injection

目的:建立复尔康注射液中挥发性和非挥发性成分HPLC特征图谱。方法:以蒿酮为参照物,色谱柱:Dikma Kromasil C18柱(250 mm×4.6 mm,5μm);流动相:乙腈-0.1%磷酸溶液,梯度洗脱;分段变波长测定;流速:1 mL.min-1;柱温:30℃。结果:建立了复尔康注射液的HPLC特征图谱,并标定了33个共有峰,共有峰的参数符合"中药注射剂特征图谱技术要求"的有关规定。结论:方法简便,可靠,建立的特征图谱检测标准,能同时控制复尔康注射液中挥发性和非挥发性成分,可作为复尔康注射液质量评价的重要依据之一。

Objective：To establish the HPLC specific chromatogram of volatile constituents and involatile constituents in Fuerkang injection.Methods：Artemisia ketone was used as the reference substance.The separation was carried out on a Dikma Kromasil C18 column（250 mm×4.6 mm,5 μm）.The mobile phase was acetonitrile-0.1% phosphoric acid solution with gradient elution and changeable wavelength detection.The flow rate was 1 mL·min-1,and the column temperature was 30 ℃.Results：It had 33 common peaks,the parameter of which accorded with the stipulation of ＂Traditional Chinese Medicinal Injection Fingerprint Technical Requirements＂.Conclusion：This method is simple,reliable and can be used in quality evaluation of Fuerkang injection.