HPLC法测定灯盏花素注射液中野黄芩苷含量及有关物质

目的: 建立用高效液相色谱法测定灯盏花素注射液中野黄芩苷含量及其有关物质。 方法: 采用Agilent TC C₁₈(5 μm,4.6 mm×250 mm)色谱柱,以甲醇-0.1 mol·L^-1醋酸铵溶液(用磷酸调节pH 3.0)(32∶ 68)为流动相,流速1.0 mL·min^-1,检测波长335 nm。 结果: 主峰和相邻杂质峰能较好地分离;野黄芩苷浓度在26.02~312.24 μg·mL^-1范围内具有良好的线性关系(r=0.9994,n=5);最低检出量为2 ng;灯盏花素注射液中的主要有关物质为灯盏花甲素。 结论: 本法专属准确,可用于灯盏花素注射液的质量控制。

Objective: To establish an RP-HPLC method for the determination of breviscapine injection and its related substances. Methods: In this HPLC method,Agilent TC C₁₈(5 μm,4.6 mm×250 mm) column was adopted,the mobile phase consisted of methanol-0.1 mol·L^-1 ammonium acetate(adjusted to pH 3.0 with phosphoric acid)(32∶ 68) at the flow rate of 1.0 mL·min^-1 with the detection wavelength of 335 nm. Results: The prominent peak and the neighbor subsidiary peak could be completely separated by the methed.The standard curve was linear in the range of 26.02-312.24 μg·mL^-1(r=0.9994,n=5),with the detection limit of 2 ng.The prominent related substance was 4'-hydroxybaicalein-7-O-β-D-pyrangluconatemethyleste. Conclusion: The method is proved to be selective,accurate and suitable for the quality control of breviscapine injection.