目的探讨多孔层填料的新型色谱柱,建立注射用益气复脉(冻干)快速检测分析的方法。方法采用AgilentPoroshell 120 SB-C18柱(4.6 mm×100 mm,2.7μm),乙腈-0.05%磷酸梯度洗脱,流速为0.5 ml/min,检测波长为203 nm。结果提取出注射用益气复脉(冻干)的高效液相色谱特征检测图谱,分析时间与UHPLC法分析时间相近,确定了22个共有峰,建立了该制剂的HPLC法的高效快速分离的分析方法。结论与传统的高效液相色谱相比,该法具有分析速度快、灵敏度高、节约溶剂等优点;与UHPLC相比,该法具有经济、简便优势,可以有效地控制注射用益气复脉(冻干)的质量。
Objective To establish a rapid chromatography analysis method for quality control of Yiqifumai Injection.Methods An Agilent Poroshell 120 SB-C18(4.6 mm×100 mm,2.7 μm) column was used.Gradient elution was optimized and the final mobile phase consisted of phosphoric acid(0.05,V/V) and acetonitrile at a flow rate of 0.5 ml/min and at the wavelength of 203 nm.Results A rapid and effective method for separation of Yiqifumai Injection was established.Conclusion Compared to traditional HPLC,this method is rapid and sensitive.Additionally,this method provides higher resolution and saves reagents,applicable to quality control of Yiqifumai Injection.