HPLC-DAD法同时测定谷红注射液中7个组分的含量

目的: 建立HPLC-DAD法同时测定谷红注射液中乙酰谷酰胺、尿苷、腺苷、鸟苷、紫丁香苷、羟基红花黄色素A和脱水红花黄色素B 7个有效成分的含量。方法: 采用Alltima^TM C₁₈色谱柱(4.6 mm×250 mm,5 μm),以0.1%甲酸水溶液-乙腈为流动相,梯度洗脱,流速0.9 mL·min^-1,柱温30 ℃,检测波长为210、260、403 nm。结果: 7个组分的峰面积与浓度的线性关系良好(r≥0.999 6);加样回收率为99.12%~100.7%。10个批次谷红注射液中7个组分的含量分别为27.26~27.89、62.23~84.30、44.38~58.71、40.15~43.18、63.20~69.45、410.69 ~ 436.09、0.99~1.78 μg·mL^-1。结论: 所建立的方法用于谷红注射液多组分的含量测定准确、可靠,重复性好,可作为谷红注射液质量控制的参考。

Objective: To establish an HPLC-DAD method for simultaneous determination of aceglutamide,uridine,adenosine,guanosine,syringin,hydroxysafflower yellow A and anhydrosafflor yellow B in Guhong injection. Methods: HPLC separation was performed on an Alltima^TM C₁₈ column)4.6 mm×250 mm,5 μm)with the gradient elution of 0.1% formic acid aqueous solution-acetonitrile at a flow rate of 0.9 mL·min^-1.The column temperature was at 30 ℃ and the detection wavelengths were set at 210,260 and 403 nm. Results: The peak areas and the concentrations of seven analytes all showed good linear relationship(r≥0.999 6)and the spike recoveries varied from 99.12% to 100.7%.In ten batches of Guhong injection,the concentrations of seven components were 27.26-27.89 μg·mL^-1,62.23-84.30 μg·mL^-1,44.38-58.71 μg·mL^-1,40.15-43.18 μg·mL^-1,63.20-69.45 μg·mL^-1,410.69-436.09 μg·mL^-1 and 0.99-1.78 μg·mL^-1,respectively. Conclusion: The established HPLC-DAD method for determination is accurate,reliable and well reproducible,which can be used as a reference for quality control of Guhong injection.