Review on Analytical Method Validation on Tirzepatide
DOI:
https://doi.org/10.22270/ajprd.v13i5.1632Abstract
Background: - Type 2 diabetes mellitus (T2DM), obesity, cardiovascular diseases in T2DM, heart failure, non- alcoholic steato hepatitis, obstructive sleep apnea, and obesity-related mortality and morbidity are among the conditions for which Eli Lilly is developing Tirzepatide. As a supplement to diet and exercise, Tirzepatidewas initially approved in the USAin May2022 to help adults with type 2 diabetes improve their glycaemic control. Tirzepatide is a novel antidiabetic medication, single-molecule agonistoftheglucose-dependentinsulinotropicpolypeptideandglucagon-like peptide-1 receptors. It is marketed under the brand names MOUNJARO and ZEPBOUND.
Method:-Techniques such as Reversed-phase High-performance liquid chromatography (RP-HPLC), High-performance liquid chromatography (HPLC), Ultraviolet spectroscopy (UV spectroscopy), Fluorescence spectroscopy, and others have been used for analysis.
Conclusion: - An HPLC Method Validated using a Quality-by-Design (QBD) approach concludes that the method is linear, accurate, precise, and robust for the Quality control of tirzepatide in bulk and dosage forms and LC-MS bioanalytical method for quantifying tirzepatide in human plasma is typically concluded to be specific, sensitive, and accurate for pharmacokinetic studies.
Downloads
References
Munirah S. O. Alhar, Walaa I. El-Sofany, Aljazi Abdullah Al Rashidi, Khaled Hamden, Protective Effects of Isolated Curcumin From Curcuma longa on Key Enzymes Involvedin the Insulins signaling Pathway and Digestive and Metabolic Enzymes Associated With Obesity, Type 2 Diabetes, and Hypertension, Journal of Diabetes Research,
Chavda, V.P.; Ajabiya, J.; Teli, D.; Bojarska, J.; Apostolopoulos, V. Tirzepatide, a New Era of Dual-Targeted Treatment for Diabetes and Obesity: A Mini-Review. Molecules 2022; 27:4315
Ashraf AR, Mackey TK, Vida RG, Kulcsár G, Schmidt J, Balázs O, Domián BM, Li J, Csákó I, Fittler AMultifactor Quality and Safety Analysis of Semaglutide Products Sold by Online Sellers without a Prescription: Market Surveillance, Content Analysis, and Product Purchase Evaluation StudyJ Med Internet Res 2024;26:e65440
Bitne VN, Gaware VM, Department of Quality Assurance, PRES’S College of Pharmacy (For Women), Chincholi, Nashik, Asian Journal of Pharmaceutical Research and Development. (2025); 13(3):000-000.
Moneim, M.M.A., Kamal, M.F.& Hamdy M.M.A. RGB Tirzepatide Whitness Of Bio analytical Chromatographic Tool Using Fluorescence for Quantitation of Overview on Recent Analytical Methodologies for the Determination of Anti obesity Glucagon- like Peptides-1Receptor Agonists. Delta University Scientific Journal, 2024; 7(2):17-23.
Ergin Kızılçay, G., ErtürkToker, S. A New and Green Analytical Method for the Determination of Glucagon‑Like Peptide‑1 Analogue Semaglutide in Subcutaneous and Oral Pharmaceutical Preparations. Int J Pept Res Ther 31, 14 (2025).
Mansour, N. M., El-Masry, A. A., El-Sherbiny, D. T., & Moustafa, M. A. (2024). White analytical insight for sensitive fluorescent determination of semaglutide and tirzepatide in pharmaceuticals and- biological matrices. Spectrochimica Act Part A: Molecular and Biomolecular Spectroscopy, 313, 124159.
Vyas, A., Gajjar, D.J., Dudhrejiya, A., Patel, A.,Gavit, H. Comprehensive review of tirzepatide: Mechanism, chemistry, analytical method and clinical development in diabetes management. Journal of Medicinal and Nanomaterial Chemistry, 2025; 7(2): 181-199.
International Conference on Harmonization (ICH) of technical requirements for the Registration of pharmaceuticals for human use, Validation of analytical procedures: text and methodology, Q2 (R1), Geneva 2005.
Eli Lilly and Company. (2023, November8).FDA Approves Lilly's Zepbound™ (tirzepatide) for chronic weight management [Press release].
Eli Lilly and Company. (2022, May 13). FDA approves Lilly's Mounjaro™ (tirzepatide) injection, the first and only GIP and GLP-1 receptor agonist for the treatment of adults with type 2 diabetes [Press release].
National Center for Biotechnology Information (2025). PubChem Compound Summary for CID 156588324, Tirzepatide. Retrieved September 17, 2025.
Downloads
Published
How to Cite
Issue
Section
License
Copyright (c) 2025 Asmita Mishra, Vipal Patel, Binal Prajapati, Helly Shah
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
AUTHORS WHO PUBLISH WITH THIS JOURNAL AGREE TO THE FOLLOWING TERMS:
Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution-NonCommercial 4.0 Unported License. that allows others to share the work with an acknowledgment of the work's authorship and initial publication in this journal.
Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgment of its initial publication in this journal.
Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access).
. 