反相高效液相色谱法测定氯高铁血红素的有关物质

目的: 建立反相高效液相色谱法测定氯高铁血红素原料药的有关物质。 方法: 采用ODS色谱柱(150 mm×4.6 mm,5 μm);以甲醇-乙腈-0.05 mol·L^-1醋酸铵缓冲液(冰醋酸调pH 3.0)-吡啶(31: 31: 38: 0.4)为流动相;检测波长为399 nm;流速1.0 mL·min^-1;柱温30℃。 结果: 氯高铁血红素浓度在0.0205 ~0.1025 μg·mL^-1范围内,浓度与主要杂质峰面积呈良好的线性关系(r=0.9999),重复性试验中单个杂质含量的RSD为1.8%(n=6)。 结论: 该方法简便、快速、准确且重复性好,可作为氯高铁血红素原料药的有关物质控制方法。

Objective: To establish a RP-HPLC method for the related substances of hemin. Methods: An ODS column (150 mm×4.6 mm, 5 μm) was used with a mobile phase of methanol-acetonitrile-0.05% ammonium acetate buffer solution (adjusted to pH3.0 with glacial acetic acid)-pyridine (31: 31: 38: 0.4);the detection wavelength was set at 399 nm; the flow rate was 1.0 mL·min^-1 and the column temperature was maintained at 30℃. Results: A good linearity of the concentration and main impurity peak area was achieved in the concentration range of 0.0205-0.1025 μg·mL^-1 (r=0.9999), RSD of repeatability for single impurity was 1.8% (n=6). Conclusion: The method is simple, rapid, precise and reproducible.It can be used for quality control of hemin.

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