液质联用快速确定尼群地平原料药中的杂质

目的: 利用液质联用技术对尼群地平原料药中的2个杂质进行在线的质谱分析。 方法: 采用C₁₈(250 mm×4.6 mm,5 μm)色谱柱,流动相为甲醇-水(70:30),流速为1.0 mL·min^-1;Agilent 6320质谱仪,离子源为ESI,质量分析器为离子阱,检测模式为正离子。 结果: 直接推断出了2个杂质可能的化学结构。 结论: 检测结果对于尼群地平原料药的杂质分析、质量控制和合成工艺的改进具有重要作用。

Objective: To establish the method for the detection of impurities in nitrendipine bulk drug by means of high-performance liquid chromatography coupled with tandem mass spectrometry(HPLC-MSⁿ). Methods: The identification of nitrendipine was carried out.Separation was performed on C₁₈ column(250 mm×4.6 mm,5 μm),the mobile phase consisted of methanol-water(70:30)and the flow rate was 1.0 mL·min^-1;An Agilent 6320 ion trap mass spectrometer with an ESI source was used for LC-MSⁿ analysis,utilizing the positive detection mode. Results: The chemical structures of two impurities were elucidated. Conclusion: The results of determination offer the scientific data for studying the origin of the impurities of nitrendipine and improving its quality.

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