Review on QBD Approaches to HPLC Method Development and Validation on Tirzepatide
DOI:
https://doi.org/10.22270/ajprd.v14i2.1717Abstract
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.
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