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Stream/Area:
-
Subject:
-
Paper ID:
IJSREM65025
Volume:
10 |
6 |
Jun 2026
Pages:
1-5
Publication Frequency:
Monthly (12 issues per year)
License:International Journal of Scientific Research in Engineering and Management follows the Creative Commons Attribution 4.0 (CC BY 4.0) License, allowing free use and distribution with proper attribution.
Quality Assurance
RBTB
Dept. of Pharmaceutical Sciences,
Rajesh Bhiayya Tope College of Pharmacy, Chh.Sambhajinagar.
Dept. of Pharmaceutical Sciences,
Rajesh Bhiayya Tope College of Pharmacy, Chh.Sambhajinagar.
Dept. of Pharmaceutical Sciences,
Rajesh Bhiayya Tope College of Pharmacy, Chh.Sambhajinagar.
Tirzepatide, a novel dual GIP and GLP-1 receptor agonist, requires highly sensitive and robust analytical methods for quality control. This study describes a systematic Quality by Design (QbD) approach for the development and validation of a stability-indicating RP-HPLC method. The Analytical Target Profile (ATP) was defined to ensure a short runtime with high resolution. Critical Quality Attributes (CQAs), including the tailing factor (T leq 1.5) and resolution (Rs > 2.0), were monitored against Critical Method Parameters (CMPs) such as mobile phase composition (Acetonitrile percentage), flow rate, and buffer pH. Using a Central Composite Design (CCD), the design space was established to identify the Method Operable Design Region (MODR). Forced degradation studies under acidic, alkaline, and oxidative conditions confirmed the method’s stability-indicating nature, as degradants were well-resolved from the Tirzepatide peak. The results indicate that the proposed QbD-based method is cost-effective, robust, and highly suitable for routine pharmaceutical analysis.
KEYWORDS
The evaluation of robustness should be considered during the development phase and depends on the type of procedure under study. It should show the reliability of an analysis with respect to deliberate variations in method parameters.” More generally, a method should be rugged, i.e. insensitive to factors external to the method, such as where it is run and by whom. AQbD approach to method development facilitates achieving these goals
1. Chavda VP, 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 Jul 5;27(13):4315. 2. Nauck MA, D’Alessio DA. Tirzepatide, a dual GIP/GLP-1 receptor co-agonist for the treatment of type 2 diabetes with unmatched effectiveness regrading glycaemic control and body weight reduction. Cardiovascular diabetology. 2022 Dec;21(1):1-6. 3. Chavda VP, 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 Jul 5;27(13):4315. 4. Jastreboff AM, Aronne LJ, Ahmad NN, Wharton S, Connery L, Alves B, Kiyosue A, Zhang S, Liu B, Bunck MC, Stefanski A. Tirzepatide Once Weekly for the Treatment of Obesity. New England Journal of Medicine. 2022 Jun 4. 5. PubChem. Bethesda (MD): National Library of Medicine (US), National Center for Biotechnology Information; 2004-. bChem Compound Summary for CID 156588324, Tirzepatide; [cited 2022 Dec. 4] 6. Erni F. Use of high-performance liquid chromatography in the pharmaceutical industry. Journal of Chromatography A. 1990 May 16;507:141-9. 7. Nikolin B, Imamović B, Medanhodzić-Vuk S, Sober M. High perfomance liquid chromatography in pharmaceutical analyses. Bosn J Basic Med Sci. 2004 May;4(2):5-9 8. Ngwa G. Forced degradation as an integral part of HPLC stabilityindicating method development. Drug delivery technology. 2010;10(5):56-9. 9. Godela R, Gummadi S. A simple stability indicating RP-HPLC-DAD method for concurrent analysis of Tenofovir Disoproxil Fumarate, Doravirine and Lamivudine in pure blend and their combined film coated tablets. InAnnales Pharmaceutiques Françaises 2021; 79, (6):640-651. 10. 13. Hotha KK, Reddy SPK, Raju VK, Ravindranath LK. Forced Degradation Studies: Practical Approach - Overview Of Regulatory Guidance And Literature For The Drug Products And Drug Substances. Int Res J Pharm 2013;4:78-85.
Publication Date
6/15/2026
Peer Review Type
Double-Blind Peer Review
Review Rounds: 2
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