Forced Degradation Study of an Anti‐Diabetic Drug Imeglimin: Impurity Profiling and Structure Elucidation Using LC‐Q‐ToF‐MS/MS and NMR
An HPLC method, capable of separating the Imeglimin and its four DPs, was developed and validated as per the ICH Q2(R1) guideline. Structure elucidation reveals a variety of products with metformin as one of the identified DPs along with a metabolite. The toxicity potential of DPs was assessed through docking studies.
Authors
- Sibu Sen (ORCID: https://orcid.org/0000-0002-2633-9294)
- Gananadhamu Samanthula (ORCID: https://orcid.org/0000-0002-6389-5994)
- Amol G. Dikundwar (ORCID: https://orcid.org/0000-0002-7149-1279)
- Shiva Kumar Gogikar
- Shivashankar Pathinti
Institutions
- National Institute of Pharmaceutical Education and Research - Ahmedabad (IN)
Publication Details
- Journal
- Rapid Communications in Mass Spectrometry
- Published
- 2024-12-10
- DOI
- https://doi.org/10.1002/rcm.9960
- Citations
- 8
- Primary Topic
- Analytical Methods in Pharmaceuticals
- Type
- article
- Field-Weighted Citation Impact
- 1.89
Funders
- Department of Science and Technology, Ministry of Science and Technology, India