AQbD-based development of a stability-indicating UHPLC-PDA-QDa method for triptorelin in parenteral formulations

Area of Science:

• Analytical Chemistry
• Pharmaceutical Sciences

Background:

• Triptorelin is a peptide-based drug used in various therapeutic applications.
• Accurate quantification and stability assessment of peptide formulations are crucial for ensuring drug efficacy and safety.
• Existing analytical methods may lack the robustness or specificity required for complex suspension formulations.

Purpose of the Study:

• To develop and validate a robust, stability-indicating analytical method for triptorelin quantification in suspension formulations.
• To apply the Analytical Quality by Design (AQbD) framework for systematic method development and optimization.
• To ensure the method's suitability for routine quality control and regulatory submissions.

Main Methods:

• Reverse-phase ultra-high-performance liquid chromatography (RP-UHPLC) was employed.
• The Analytical Quality by Design (AQbD) framework guided the systematic optimization of critical method parameters.
• Forced degradation studies (acidic, basic, oxidative, thermal) were conducted to assess stability-indicating capability.

Main Results:

• Optimal chromatographic conditions were established using a YMC Triart C18 column with a specific gradient elution profile.
• The developed RP-UHPLC method demonstrated excellent specificity and stability-indicating properties.
• The method proved effective for quantifying triptorelin in suspension formulations under various stress conditions.

Conclusions:

• A robust and validated stability-indicating RP-UHPLC method for triptorelin quantification in suspension formulations was successfully developed.
• The AQbD approach facilitated an efficient and science-driven method development process.
• The method is suitable for routine quality control and regulatory applications in peptide drug analysis.