Nanoparticle Formulation Composition Analysis by Liquid Chromatography on Reversed-Phase Monolithic Silica
Ekaterina Tsarenko1,2, Ulrich S Schubert1,2, Ivo Nischang1,2
1Laboratory of Organic and Macromolecular Chemistry (IOMC), Friedrich Schiller University Jena, Humboldtstr. 10, 07743 Jena, Germany.
Analytical Chemistry
|December 22, 2022
Summary
This study introduces a new method for analyzing nanoparticle drug formulations. Reversed-phase monolithic silica chromatography allows for the simultaneous, quantitative analysis of polymers and encapsulated drugs in nanoparticles.
Area of Science:
- Nanotechnology and Materials Science
- Pharmaceutical Sciences and Drug Delivery
Background:
- Multifunctional nanoparticles (NPs) show promise for medical applications, but quantitative compositional analysis remains a challenge.
- Accurate analysis of polymer matrix and encapsulated drugs is crucial for NP formulation development and quality control.
Purpose of the Study:
- To develop a method for the quantitative, simultaneous analysis of poly(lactic-co-glycolic acid) (PLGA) polymer and encapsulated drugs in NPs.
- To assess the utility of reversed-phase monolithic silica chromatography for analyzing complex NP formulations.
Main Methods:
- Poly(lactic-co-glycolic acid) (PLGA) NPs were formulated using nanoprecipitation.
- NP size and integrity were analyzed using dynamic light scattering (DLS) and scanning electron microscopy (SEM).
- Quantitative compositional analysis was performed using liquid chromatography on reversed-phase silica monolithic columns.
Main Results:
- A single chromatographic run allowed for the simultaneous quantification of small molecule drugs (ibuprofen, dexamethasone, dexamethasone acetate) and the PLGA polymer.
- Chromatographic separation was based on hydrophobicity, correlating drug loading with retention times and achieving high resolution from the PLGA matrix.
- The method demonstrated repeatability and simultaneous analysis of both drug molecules and the polymer.
Conclusions:
- Reversed-phase monolithic silica chromatography is a viable strategy for the simultaneous and quantitative analysis of drugs and polymers in NP formulations.
- This approach offers a valuable tool for the analysis of diverse polymer systems and drug components in multifunctional drug delivery systems.
- The developed method can aid in the quality control and development of advanced nanoparticle-based therapeutics.
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