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AQbD-Based UPLC-ELSD Method for Quantifying Medium Chain Triglycerides in Labrafac™ WL 1349 for Nanoemulsion

Alessio Gaggero1, Viktoria Marko1, Dalibor Jeremic2

  • 1Research Center Pharmaceutical Engineering GmbH, 8010 Graz, Austria.

Molecules (Basel, Switzerland)
|February 13, 2025
PubMed
Summary

A new UPLC-ELSD method quantifies Medium-Chain Triglycerides (MCTs) in lipid excipients, meeting regulatory guidelines. This Analytical Quality by Design (AQbD) approach ensures robust and cost-effective analysis for nanoemulsion applications.

Keywords:
analytical quality by designevaporative light scattering detectionmedium chain triglyceridesnanoemulsions

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Area of Science:

  • Analytical Chemistry
  • Pharmaceutical Sciences

Background:

  • Lipid-based excipients like Labrafac™ WL 1349 are crucial for nanoemulsion formulations.
  • Regulatory bodies like ICH (International Council for Harmonisation) have updated guidelines (Q2 (R2), Q14) for analytical method validation and lifecycle management.
  • Accurate quantification of Medium-Chain Triglycerides (MCTs) is essential for quality control of these excipients.

Purpose of the Study:

  • To develop and validate a robust Ultra-Performance Liquid Chromatography with Evaporative Light Scattering Detection (UPLC-ELSD) method for quantifying MCTs in Labrafac™ WL 1349.
  • To implement Analytical Quality by Design (AQbD) principles for method development and lifecycle management.
  • To ensure the method meets stringent regulatory standards for pharmaceutical excipient analysis.

Main Methods:

  • Method development utilized Analytical Quality by Design (AQbD) principles, optimizing key parameters like mobile phase composition, column type, flow rate, and temperature.
  • A Waters Acquity HSS T3 column was used under specific conditions: 33 °C, methanol/water mobile phase with formic acid, and a flow rate of 0.41 mL/min.
  • Forced degradation studies (hydrolytic, oxidative, thermal) were conducted to assess method stability and robustness.

Main Results:

  • The UPLC-ELSD method demonstrated excellent quantification of MCTs across a wide concentration range, fitting a cubic model.
  • Optimal chromatographic conditions were established, ensuring method robustness and reliability.
  • Forced degradation studies confirmed the method's suitability for analyzing samples under various stress conditions, including stability testing.

Conclusions:

  • The developed UPLC-ELSD method, guided by AQbD, provides a validated, regulatory-compliant, and cost-effective approach for MCT quantification in lipid excipients.
  • This method supports the lifecycle management of analytical procedures for lipid-based excipients used in nanoemulsion applications.
  • The AQbD-driven approach enhances scientific understanding and facilitates efficient quality control of pharmaceutical ingredients.