生脉注射液HPLC指纹图谱的建立

Establishment of HPLC fingerprint of Shengmai injection

目的:建立生脉注射液的HPLC指纹图谱。方法:采用Waters Symmetry ShieldTMRP18(4.6 mm×250 mm,5μm)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 ShieldTM 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.