生脉注射液HPLC指纹图谱的建立

目的: 建立生脉注射液的HPLC指纹图谱。 方法: 采用Waters Symmetry Shield^TM RP18(4.6 mm×250 mm,5 μm)色谱柱,以乙腈-水为流动相,梯度洗脱,流速为1 mL·min^-1,检测波长203 nm,柱温30℃。 结果: 本色谱条件下生脉注射液各成分得到了良好分离,指纹图谱由23个特征峰组成。 结论: 所建立的指纹图谱分离效果好,信息量大,可作为生脉注射液的指纹图谱使用,以便更好地控制该产品的质量。

Objective: To establish HPLC fingerprint of Shengmai injection. Methods: A Waters Symmetry Shield^TM RP18(4.6 mm×250 mm,5 μm)was adopted,acetonitrile-water(gradient elution) system was used as a mobile phase at flow rate of 1 mL·min^-1,the detection wavelength was 203 nm,and colum temperature was set at 30℃. Results: According to the selected chromatographic conditions,standard fingerprint consisting of 23 communal peaks was obtained. Conclusion: The fingerprint established has the good separate effect and includes a lot message.It should be used as fingerprint,so that the quality of Shengmai injection can be controlled better.

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