HPLC测定丹参素冰片酯脂肪乳注射液含量及有关物质

目的: 建立丹参素冰片酯脂肪乳注射液含量测定及有关物质检查方法。 方法: 采用高效液相色谱法。色谱柱:Kromasil C₁₈(150 mm×4.6 mm,5 μm)色谱柱,流动相:乙腈-0.2%甲酸水(42:58),流速为1.0 mL·min^-1,检测波长280 nm,进样体积20 μL。 结果: 试验结果表明,HPLC法检测主峰与杂质峰有较好的分离度,且重复性较好;丹参素冰片酯的浓度在5~60 μg·mL^-1范围内与峰面积呈良好线性关系(r=1.000),平均回收率为98.2%(n=9)。 结论: 该法操作简便,结果可靠,适用于丹参素冰片酯脂肪乳注射液含量测定及有关物质检查。

Objective: To establish a method to determine the content and related substances of Danshensu Borneol Ester fat emulsion injection. Methods: The experimental conditions were as follows: Kromasil C₁₈ column(150 mm×4.6 mm, 5 μm), acetonitrile-0.2% formic acid in water(42:58) as mobile phase,the flow rate: 1.0 mL·min^-1 ,the injection volume: 20 μL, and detection wavelength was set at 280 nm. Results: The main peak and impurity peaks have good resolution and repeatability. The calibration curve was linear in the range of 5-60 μg·mL^-1(r=1.000). The average recovery was 98.2%(n=9). Conclusion: The method is simple, rapid, sensitive and accurate. It is suitable for determination of the content and related substances of Danshensu Borneol Ester fat emulsion injection.

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