康艾注射液UPLC/MS指纹图谱研究

目的:建立康艾注射液的UPLC/MS指纹图谱。方法:采用Waters ACQUITY UPLC BEH C₁₈（50mm×2.1mm,1.7μm）进行分离,乙腈-20mmol·L^-1醋酸铵溶液梯度洗脱,流速:0.4ml·min^-1。离子化模式:ESI⁺。结果:对15批康艾注射液样品进行检测,建立了UPLC/MS指纹图谱并标示了8个共有指纹峰。各共有峰相对保留时间变化的RSD均在0.5%之内。结论:该方法准确、重复性好,为进一步质量标准化研究和控制提供依据。

Study on UPLC/MS Fingerprint of Kang' ai Injection

Objective： To establish the UPLC/MS fingerprint of Kang＇ ai injection. Method： The separation was performed on a Waters ACQUITY UPLC^ BEH C18（50 mm ×2. 1 ram,1.7 μm）column with acetonitrile -20 mmol· L^-1 ammonium acetate with a flow rate of 0.4 ml·min ^-1 by gradient elution. Ion mode was ESI^ ＋. Result： Eight common peaks in UPLC/MS fingerprint of Kang＇ ai injection were obtained after 15 batches of samples were tested under the selected UPLC and mass conditions. Variations in the relative retention time of 8 identified common peaks were all below 0. 5%. Conclusion： The analytical method for Kang＇ ai injection is precise and reliable. The research would be helpful to offer an effective pattern for the quality control of Kangai iniection.