Author(s):
Chandani Bhushan Patil, Amitkumar Rajkumar Dhankani, Mansi Amitkumar Dhankani, Sunil Pandit Pawar
Email(s):
patilchandani836@gmail.com
DOI:
10.52711/2231-5675.2026.00031 
Address:
Chandani Bhushan Patil, Amitkumar Rajkumar Dhankani, Mansi Amitkumar Dhankani, Sunil Pandit Pawar
P.S.G.V.P. Mandal's College of Pharmacy, Tal - Shahada, Dist. Nandurbar, Pin Code – 425409, Maharashtra, India.
*Corresponding Author
Published In:
Volume - 16,
Issue - 3,
Year - 2026
ABSTRACT:
Imeglimin hydrochloride acts as an agent that enhances insulin sensitivity, leading to improved communication between cells in organs such as the liver and muscles. It also reduces hepatic glucose production compared to normal conditions. Additionally, imeglimin enhances the body's ability to produce insulin in response to elevated glucose levels and helps preserve pancreatic ß-cell function. Based on existing literature, various analytical methods have been developed for the analysis of imeglimin hydrochloride, and this review compiles these methods. The drug has been analyzed using techniques such as stability-indicating assay methods, High-Performance Liquid Chromatography (HPLC), High-Performance Thin-Layer Chromatography (HPTLC), and Reverse-Phase High-Performance Liquid Chromatography (RP-HPLC), owing to their reliability, precision, and accuracy. Furthermore, this review includes important aspects of method development, such as the types of columns used, detection wavelengths, and mobile phase compositions. In accordance with guidelines established by international organizations such as the International Council for Harmonisation (ICH) and other regulatory authorities, critical validation parameters—including linearity, accuracy, precision, limit of detection (LOD), and limit of quantification (LOQ)—are thoroughly evaluated.
Cite this article:
Chandani Bhushan Patil, Amitkumar Rajkumar Dhankani, Mansi Amitkumar Dhankani, Sunil Pandit Pawar. Imeglimin Hydrochloride: Analytical and Chromatographic Methodology. Asian Journal of Pharmaceutical Analysis. 2026; 16(3):204-9. doi: 10.52711/2231-5675.2026.00031
Cite(Electronic):
Chandani Bhushan Patil, Amitkumar Rajkumar Dhankani, Mansi Amitkumar Dhankani, Sunil Pandit Pawar. Imeglimin Hydrochloride: Analytical and Chromatographic Methodology. Asian Journal of Pharmaceutical Analysis. 2026; 16(3):204-9. doi: 10.52711/2231-5675.2026.00031 Available on: https://ajpaonline.com/AbstractView.aspx?PID=2026-16-3-7
REFERENCE:
1. Vuylsteke V, Chastain LM, Maggu GA, Brown C. Imeglimin: A potential new multi-target drug for type 2 diabetes. Drugs R D. 2015; 15:227–32. doi: 10.1007/s40268-015-0099-3.
2. Yendapally R, Sikazwe D, Kim SS. et al. A review of phenformin, metformin, and imeglimin. Drug Dev Res. 2020; 81: 390–401. doi:10.1002/ddr.21636.
3. Nagamine J. Pharmacological profile and clinical efficacy of imeglimin hydrochloride. Folia Pharmacol Jpn. 2023; 158(2): 193-202
4. Pirags V, Lebovitz H, Fouqueray P (2010) Imeglimin, a novel glimin oral antidiabetic, exhibits good glycaemic control in type 2 diabetes mellitus patients. Presented at the 46th EASD Annual Meeting, Stockholm, Sweden
5. Onyango EM, Onyango BM. The Rise of Noncommunicable Diseases in Kenya: An Examination of the Time Trends and Contribution of the Changes in Diet and Physical Inactivity. Journal of Epidemiology and Global Health. 2018; 8(1-2): 1.
6. Li Y, Lou N, Liu X, Zhuang X, Chen S. Exploring new mechanisms of imeglimin in diabetes treatment. Biomed Pharmacother. 2024; 175: 116755. dysfunction. Biomedicine & Pharmacotherapy, 175, 116755.
7. Hallakou‐Bozec, S., Vial, G., Kergoat, M., Fouqueray, P., Bolze, S., Borel, A., Fontaine, E., & Moller, D. E. Mechanism of action of Imeglimin: A novel therapeutic agent for type 2 diabetes. Diabetes Obesity and Metabolism. 2020; 23(3): 664–673.
8. Validation of Analytical procedure; Text and methodology Q2(R1), International Conference on Harmonisation of technical requirements for human use, ICH Harmonized tripartite guidelines, 2005
9. Fouqueray, P., Delporte, C., & Scheen, A. J. Imeglimin: A clinical pharmacology review. Clinical Pharmacokinetics. 2023; 62(5): 423-437 https://doi.org/10.1007/s40262-023-01234-5
10. Fouqueray, P., Chevalier, C., & Bolze, S. Pharmacokinetics of Imeglimin in Caucasian and Japanese Healthy Subjects. Clinical Drug Investigation. 2022; 42(9): 721–732.
11. Reddy V.P, Rajan T.V.S, Kumar A. N, A Review on Analytical Method Validation. Int J Rev Life Sci. 1: 141-144.
12. Chinmaya K. S, Muvvala S., Nalini K. S., Validation of Analytical Methods: A Review, International Journal of Chromatography and Separation Techniques. 2018; 1
13. Vidushi Y, Meenakshi B. A review on HPLC method development and validation. Res J Life Sci. 2017; 2(6): 178.
14. Kumar A, Kishore L, Kaur N, Nair A. Method development and validation: Skills and tricks. Chronicles of Young Scientists. 2012; 3(1).
15. Hokanson GC. A life cycle approach to the validation of analytical methods during pharmaceutical product development part I: The initial validation process. Pharm.Tech.1994; 118-30.
16. Sahoo NK, Sahu M, Veerachamy A, Lalitha BV, Moharana AK, Sahoo CK. Quantification and validation of simvastatin and ezetimibe in bulk drugs and combined dosage form by reverse phase liquid chromatographic method (RPLC). Pharm.Methods. 2015; 6(2): 115-9.
17. Sahoo NK, Sahu M, Alagarsamy V, Srividya B, Sahoo CK. Current status of two-dimensional gel validation of assay indicating method development of imatinib in bulk and its capsule dosage form by liquid chromatography. Ann. Chromatogr Sep. Tech. 2015; 1(2): 1010.
18. Moharana AK, Banerjee M, SahooCK, Sahoo NK. Development and validation of RP-HPLC method for mesalamine. Asian J. of Pharmaceutical and Clinical Research. 2011; 4(Suppl.2): 71-73.
19. Renger B, Jehle H, Fischer M, Funk W. Validation of analytical procedures in pharmaceutical analytical chemistry: HPTLC assay of theophylline in an effervescent tablet. J. Planar. Chrom.1995; 8: 269-78
20. Sahoo NK, Sahu M, Praneeth P, Manjeera PSK, Lavanya K. Degradation motitoring method development and validation of spectophotometric estimation of atrovastatin calcium in bulk and tablet formulation.J. of Pharm. Biomed. Sci. 2013; 33(33): 1551-1557.
21. Patel NK, Subhaiah G, Shah H, Mohan M, Shrivastav SP. Rapid LC-ESI-MS-MS method for the simultaneous determination of clopidogrel and its carboxylic acid metabolite in human plasma.J.Chromatogr.Sci. 2008; 46: 867-875.
22. Vander HY, Nijhuis A, Verbeke JS, Vandegtnste BG, Massart DL. Guidance for robustness/ruggedness test in method validation. J Pharm Biomed Anal.2009; 24: 723-53.
23. Sahoo NK, Sahu M, Podilapu S, Rao JNI, Rani SN, Ghosh GK. Validation of assay for bulk clopidogrel and for some tablet forms by reverse phase high performance liquid chromatography. J of Taibah University for Science 2014; 8: 331-336.
24. Skoog, Douglas A.; Holler, F. James; Crouch, Stanley R. (2007). Principles of Instrumental Analysis. Belmont, Ca: Brooks/Cole, Thomson. P. 1. ISBN 978-0-495-01201-6.
25. Atole, Dipali, Rajput Hrishikesh. Ultraviolet Spectroscopy and Its Pharmaceutical Applications- A Brief Review. Asian Journal of Pharmaceutical and Clinical Research. 2018; 11: 59. 10.22159/AJPCR. 2018 V11i2.21361
26. Martin M., Guiochon, G. Effects of High Pressures in Liquid Chromatography. J. Chromatograph. A, 2005; 7(1-2): 16-38. 2.
27. Liu Y., Lee M.L. Ultrahigh Pressure Liquid Chromatography Using Elevated Temperature. Journal of Chromatography. 2006; 1104(1-2): 198–202
28. Wu N, Lippert JA, Lee ML. Practical aspects of ultrahigh pressure capillary liquid chromatography. Journal of Chromatography. 2001; 1: 9-11
29. SS. Gokul, S. Zarekar, S. Pawar. Int J.Pharm. Drug. Anal. 2017; 5: 177-184.thttp://ijpda.com.
30. G. Rao, A. Goyal. An overview on analytical method development and validation by using hplc. ThePharmaceutical and Chemical Journal. 2016; 3(2): 280-289. http://tpcj.org/download/vol-3-iss-2-2016/TPCJ2016-03-02-280-289.pdf
31. P. Tiwari and KB. Singh. A modern approach of development and validation. World Journal of Pharmaceutical Research. 2016; 5: 1616-1631. DOI: 10.20959/wjpr20169-7025.
32. Loescher CM, Morton DW, Razic S, Agatonovic-Kustrin S. High performance thin layer chromatography (HPTLC) and high-performance liquid chromatography (HPLC) for the qualitative and quantitative analysis of Calendula officinalis-advantages and limitations. J Pharm Biomed Anal. 2014 Sep; 98: 52–9.
33. Shubham Jahagirdar, Rahul Godge, Sneha Vikhe, Snehal Bornare. Estimation of Imeglimin in Pharmaceutical Tablets by RP-HPLC International Journal of Drug Delivery Technology. 2024; 14(2): 726-742.
34. Vaidehi Sunil Holey, Shailesh G. Jawarkar Analytical method development and validation of stability-indicating RP-HPLC method for Imeglimin Hydrochloride. American Journal of Pharmatech Research. 2024; 14(2): 102-116.
35. Sharanabasava Navali, Lalitha N, Mubeen. RP-HPLC method for determination of Imeglimin Hydrochloride in bulk and tablet formulation. Asian Journal of Pharmaceutical Research and Development. 2024; 12(4): 92-96.
36. Hemant Chikhale, Yogeshwari Ambekar, Saurabh Avhad, Laxmikant Borse. Development and validation of RP-HPLC method for determination of antidiabetic drug in bulk and dosage form. Journal of Chemical Health Risk. 2024; 14(4): 675-685.
37. Ajay Sanjay Salvi0, Mohini S. Khamkar, Lahu D. Hingane. Development and validation of RP-HPLC method for estimation of antidiabetic drug in bulk and tablet dosage form. Journal of Emerging Technologies and Innovative Research. 2023; 10(5): 366-378.
38. Vachala SD, Manjunath GV, Pravat Ranjan B, Shashi Prakash R, Srilakshmi KT. Yashodha K.J. Development and validation of Imeglimin Hydrochloride by UV-Visible Spectrophotometric method. International Journal of Research and Analytical Review. 2023; 10(4): 57-67.
39. Anish Jain, Love Kumar Soni, Rajesh Sharma. Development and validation of stability-indicating RP-UHPLC method for estimation of Imeglimin HCl used in treatment of metabolic disorder diabetes mellitus. International Journal of Applied Pharmaceutical. 2023; 15(6): 211-217.