A Comprehensive Review of Analytical Method Development and Validation for Imeglimin Hydrochloride.

Imeglimin Hydrochloride is a novel oral antidiabetic agent used in the management of type 2 diabetes mellitus, characterized by its unique mechanism of action targeting mitochondrial bioenergetics. The increasing therapeutic significance of Imeglimin necessitates the development of robust, accurate, and reliable analytical methods for its identification, quantification, and quality control in bulk and pharmaceutical dosage forms. This comprehensive review focuses on the various analytical techniques developed for the estimation of Imeglimin Hydrochloride, including spectroscopic methods such as UV–Visible spectrophotometry and advanced chromatographic techniques like High-Performance Liquid Chromatography (HPLC), High Performance Thin Layer Chromatography (HPTLC), and Liquid Chromatography–Mass Spectrometry (LC– MS). Emphasis is placed on method development strategies, including selection of solvents, mobile phase optimization, detection wavelength, and column characteristics to achieve optimal sensitivity and specificity.

Analytical methods, Type 2 diabetes, Glimins (mitochondrial modulators), Antidiabetic, Imeglimin hydrochloride.

1. Adhao, Vaibhav S., Shreyash P. Chaudhari, and Jaya P. Ambhore. 2024. “Stability Indicating RP-HPLC Method Development and Validation for Imeglimin HCL in Pharmaceutical Dosage Form”. hemical Science International Journal 33 (4):1-10. https://doi.org/10.9734/CSJI/2024/v33i4901 [Google Scholar] [Crossref]

2. Chandarana, C.V., Vashi, V.H., Bera, A. et al. Green bioanalytical method development and validation for estimation of Imeglimin hydrochloride using human plasma in pure form by LC–MS/MS. Futur J Pharm Sci 11, 81 (2025). https://doi.org/10.1186/s43094-025-00832-4 [Google Scholar] [Crossref]

3. Gawande, K. A., Waghulkar, V. M., & Jadhav, M. P. (Year). Bioanalytical method development and validation of antidiabetic drug: Imeglimin hydrochloride. Vidyabharati College of Pharmacy, Amravati, Maharashtra, India. [Google Scholar] [Crossref]

4. Giri, Pooja T., Et Al. "Qbd (Quality By Design) Approach: Development And Validation Of An Rp-Hplc Method For Estimating Imeglimin Hcl And Its Ketone Impurity." Int J App Pharm 17.4 (2025): 241-253. https://pubchem.ncbi.nlm.nih.gov/ [Google Scholar] [Crossref]

5. Jain, A. S. L. K., I. K. Soni, and R. A. J. E. S. H. Sharma. "Development and validation of stability indicating rp-uhplc method for the estimation of imeglimin hydrochloride used for the treatment of metabolic disorder diabetes mellitus." International Journal of Pharmaceutical Sciences 15.6 (2023): 211-217. [Google Scholar] [Crossref]

6. Lamb, Y.N. (2021). Imeglimin Hydrochloride: First Approval. Drugs 81, 1683–1690. [Google Scholar] [Crossref]

7. https://doi.org/10.1007/s40265-021-01589-9 [Google Scholar] [Crossref]

8. Mangore, M. N., Bhosale, N. R., Khade, P. H., Chavan, R. S., Chikane, P. T., & Kardile, M. S. (2025).Formulation and optimization of imeglimin-loaded nanoparticles using central composite design. Journal of Chemical Health Risks, 15(4), 2687–2696. [Google Scholar] [Crossref]

9. Mansour, F.R., Elagamy, S.H., Elbastawissy, A.B.B. et al. (2026). Stability indicating green HPLC method for Imeglimin hydrochloride determination in pharmaceutical tablets with comprehensive assessment. Sci Rep 16, 1334 . https://doi.org/10.1038/s41598-025-32999-4 [Google Scholar] [Crossref]

10. Mubeen G, Navali, S., & N, L. (2024). RP-HPLC Method for Determination of Imeglimin Hydrochloride in Bulk and Tablet Formulation. Asian Journal of Pharmaceutical Research and Development, 12(4), 92–96. https://doi.org/10.22270/ajprd.v12i4.1446 (Original work published August 15, 2024 [Google Scholar] [Crossref]

11. Pagar, O. K., Suhasini, B., & Aravinda Reddy, P. (2025). RS method for quantification of imeglimin HCl in its pure and tablet dosage form by using RP-HPLC technology. Journal of Pharmaceutical and Biomedical Analysis Letters, 13(2), 62–68. https://doi.org/10.30904/j.jpbmal.2025.4898⁠. [Google Scholar] [Crossref]

12. Parthiban, C., Renuka, G., Maheshwari, K., Rithuja, K., Kumar, K. M., & Jaswanth, K. (2025). Method development and validation for the estimation of imeglimin by UV visible spectroscopy. World Journal of Pharmacy and Pharmaceutical Sciences, 14(4), 1008–1018. [Google Scholar] [Crossref]

13. https://doi.org/10.20959/wjpps2025429434 [Google Scholar] [Crossref]

14. Pirags, V., Lebovitz, H., & Fouqueray, P. (2012). Imeglimin, a novel mitochondrial-targeting agent for type 2 diabetes treatment. Diabetes Care, 35(11), 2114–2120. [Google Scholar] [Crossref]

15. Tamil Selvan, R., et al. (2023)."A Novel method development and Validation of imeglimin HCl by UV visible spectroscopy." Int. J. in Pharm. Sci 1.12 : 852-859 [Google Scholar] [Crossref]

16. Vikhe, K.B., Sonawane, S.S.(2026). Stability Indicating RP-HPLC Method Development and Validation for Estimation of Imeglimin HCl. BioNanoSci. 16, 152 . https://doi.org/10.1007/s12668-025-02317-3 [Google Scholar] [Crossref]

• Development and Evaluation of Floating Alginate Beads of Esomeprazole
• Determination of pKa Value for Ranolazine and Atenolol Using UV Spectroscopy
• The Science of Sustained-Release Medications
• Development of Proteomics in Clinical Medicine
• Advances on Quinoline Derivatives: A Review of Synthesis and Biological Activities