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<p>The <i>N</i>-nitroso-vildagliptin impurity has been classified as genotoxic. According to the EMA, this impurity must be controlled within a limit of 15&#xa0;ppm in the vildagliptin drug substance. This work demonstrates the synthesis and characterization of the <i>N</i>-nitroso-vildagliptin impurity using IR, NMR, and LC–MS techniques. The synthesized <i>N</i>-nitroso-vildagliptin impurity was used as a reference standard for the development and validation of an LC–MS/MS method, achieving a limit of detection (LOD) of 0.44&#xa0;ppm and a limit of quantification (LOQ) of 1.46&#xa0;ppm.</p>

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N-Nitroso-Vildagliptin, A New N-Nitrosamine Drug Substance Related Impurity (NDSRI) of Vildagliptin- An Antidiabetic Drug: Synthesis, Characterization and Development of Sensitive LC–MS/MS Method

  • 期刊论文

  • 发表日期：

    2025年9月12日

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  • Vipin Kumar,
  • Lingaiah Balthu,
  • Sriram Pepakayala,
  • Yogesh Kumar Lohia,
  • Deepika Kathuria,
  • Priyanka Mathur,
  • Vikas Rathod,
  • Swapnil Sonar,
  • Sumit S. Chourasiya

摘要

The N-nitroso-vildagliptin impurity has been classified as genotoxic. According to the EMA, this impurity must be controlled within a limit of 15 ppm in the vildagliptin drug substance. This work demonstrates the synthesis and characterization of the N-nitroso-vildagliptin impurity using IR, NMR, and LC–MS techniques. The synthesized N-nitroso-vildagliptin impurity was used as a reference standard for the development and validation of an LC–MS/MS method, achieving a limit of detection (LOD) of 0.44 ppm and a limit of quantification (LOQ) of 1.46 ppm.