A versatile, quantitative analytical method for pharmaceutical relevant lipids in drug delivery systems
Dominik Jeschek1, Gabriele Lhota1, Jakob Wallner1
1Department of Biotechnology, University of Natural Resources and Applied Life Sciences, Muthgasse 11, A-1190 Vienna, Austria.
Journal of Pharmaceutical and Biomedical Analysis
|December 8, 2015
Summary
A new reversed-phase high-performance liquid chromatography (rp-HPLC) method with an evaporative light scattering detector (ELSD) enables sensitive detection of lipids and their degradation products in liposomal formulations, crucial for drug development.
Area of Science:
- Pharmaceutical Sciences
- Analytical Chemistry
- Biotechnology
Background:
- Liposomal formulations are advanced drug carrier systems requiring robust analytical characterization.
- Accurate quantification of lipid ratios and detection of hydrolysis degradation products (lysophospholipids, fatty acids) are critical challenges in liposome analysis.
Purpose of the Study:
- To develop a highly sensitive and selective analytical method for characterizing liposomal formulations.
- To enable simultaneous separation and quantification of phospholipids, their degradation products, and cholesterol.
- To support the development, characterization, and stability testing of liposomal biopharmaceuticals.
Main Methods:
- A reversed-phase high-performance liquid chromatography (rp-HPLC) method utilizing an organic solvent/trifluoroacetic acid (TFA) triggered gradient.
- Detection was performed using an evaporative light scattering detector (ELSD) with optimized gain settings.
- Simultaneous separation and quantification of 16 components, including phosphatidylcholines, phosphatidylglycerols, and cholesterol.
Main Results:
- The method achieved high sensitivity with limits of detection (LOD) ranging from 0.25–1.00 μg/mL and limits of quantification (LOQ) from 0.50–2.50 μg/mL.
- Excellent precision was demonstrated with intra-day RSD < 3% and inter-day RSD ~ 8%.
- The method showed high recovery (96–102%) and was successfully applied to analyze and assess the stability of different liposome formulations.
Conclusions:
- The developed rp-HPLC-ELSD method is sensitive, selective, accurate, and provides appropriate resolution for analyzing phospholipids and their hydrolysis products in liposomal formulations.
- The method is suitable for quality control, characterization, and stability studies of liposomal drug products.
- This analytical approach is valuable for advancing pharmaceutical research and development involving liposomal drug delivery systems.
