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<p>Imeglimin (IMG) is the first agent of the new tetrahydrotriazine-based class of oral antidiabetic drugs known as ‘glimins’. This work presents LC–ESI–MS based degradation profiling, by fragmentation-assisted structural elucidation of major degradation products of Imeglimin under forced degradation conditions. For that, first we have developed and validated a green, robust, simple and efficient RP-HPLC method to ensure its stability. The column used in the method is ACE CN 25 column (250&#xa0;mm × 4.6&#xa0;mm, 5&#xa0;µm). Acetonitrile: 20&#xa0;mM Ammonium Formate (60:40% v/v) is used as the mobile phase at a flow rate of 1.0&#xa0;ml/min. Detection was done at a detection wavelength of 245&#xa0;nm. Linearity was found over the range of 5–200&#xa0;µg/ml with correlation coefficient 0.9998. Specificity, linearity, precision, accuracy and robustness of the method were confirmed by rigorous validation in accordance with ICH requirements. Then, forced degradation studies were performed. Forced degradation led to the formation of five degradation products (DPs); Two in acidic, one in basic and two in oxidative conditions. IMG showed relatively higher stability under photolytic and thermal conditions. RP-HPLC combined with electrospray ionization tandem mass spectrometry (LC–ESI–MS) was used effectively to identify these degradation products, offering insights into their structural pathways. Greenness and sustainability of the method were proved with an AGREE score of 0.66 and a ComplexMoGAPI score of 65. This validated analytical method ensures reliable stability assessment of Imeglimin (IMG) with precise quantification and consistent monitoring of degradation in pharmaceutical dosage forms.</p>

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LC–ESI–MS Based Degradation Profiling of Imeglimin Supported by a Validated Green Stability-Indicating RP-HPLC Method

  • 期刊论文

  • 发表日期：

    2026年8月4日

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  • Kiran R. Rathod,
  • Chintankumar J. Tank

摘要

Imeglimin (IMG) is the first agent of the new tetrahydrotriazine-based class of oral antidiabetic drugs known as ‘glimins’. This work presents LC–ESI–MS based degradation profiling, by fragmentation-assisted structural elucidation of major degradation products of Imeglimin under forced degradation conditions. For that, first we have developed and validated a green, robust, simple and efficient RP-HPLC method to ensure its stability. The column used in the method is ACE CN 25 column (250 mm × 4.6 mm, 5 µm). Acetonitrile: 20 mM Ammonium Formate (60:40% v/v) is used as the mobile phase at a flow rate of 1.0 ml/min. Detection was done at a detection wavelength of 245 nm. Linearity was found over the range of 5–200 µg/ml with correlation coefficient 0.9998. Specificity, linearity, precision, accuracy and robustness of the method were confirmed by rigorous validation in accordance with ICH requirements. Then, forced degradation studies were performed. Forced degradation led to the formation of five degradation products (DPs); Two in acidic, one in basic and two in oxidative conditions. IMG showed relatively higher stability under photolytic and thermal conditions. RP-HPLC combined with electrospray ionization tandem mass spectrometry (LC–ESI–MS) was used effectively to identify these degradation products, offering insights into their structural pathways. Greenness and sustainability of the method were proved with an AGREE score of 0.66 and a ComplexMoGAPI score of 65. This validated analytical method ensures reliable stability assessment of Imeglimin (IMG) with precise quantification and consistent monitoring of degradation in pharmaceutical dosage forms.