Characterization of Dye-Loaded Poly(lactic- co -glycolic acid) Nanoparticles by Comprehensive Two-Dimensional Liquid Chromatography Combining Hydrodynamic and Reversed-Phase Liquid Chromatography.

Autor: Verduin J; Department of Chemistry and Pharmaceutical Sciences, Amsterdam Institute of Molecular and Life Sciences (AIMMS), Division of BioAnalytical Chemistry, Vrije Universiteit Amsterdam, De Boelelaan 1085, 1081 HV Amsterdam, The Netherlands.; Centre of Analytical Sciences Amsterdam (CASA), Science Park 904, 1098 XH Amsterdam, The Netherlands., Tutiš L; Department of Chemistry and Pharmaceutical Sciences, Amsterdam Institute of Molecular and Life Sciences (AIMMS), Division of BioAnalytical Chemistry, Vrije Universiteit Amsterdam, De Boelelaan 1085, 1081 HV Amsterdam, The Netherlands.; Centre of Analytical Sciences Amsterdam (CASA), Science Park 904, 1098 XH Amsterdam, The Netherlands., Becking AJ; Department of Chemistry and Pharmaceutical Sciences, Amsterdam Institute of Molecular and Life Sciences (AIMMS), Division of BioAnalytical Chemistry, Vrije Universiteit Amsterdam, De Boelelaan 1085, 1081 HV Amsterdam, The Netherlands.; Centre of Analytical Sciences Amsterdam (CASA), Science Park 904, 1098 XH Amsterdam, The Netherlands., Famili A; Synthetic Molecule Pharmaceutical Sciences, Genentech, Inc., 1 DNA Way, South San Francisco, California 94080, United States., Zhang K; Synthetic Molecule Pharmaceutical Sciences, Genentech, Inc., 1 DNA Way, South San Francisco, California 94080, United States., Pirok BWJ; Centre of Analytical Sciences Amsterdam (CASA), Science Park 904, 1098 XH Amsterdam, The Netherlands.; van 't Hoff Institute for Molecular Sciences (HIMS), Analytical-Chemistry Group, University of Amsterdam, Science Park 904, 1098 XH Amsterdam, The Netherlands., Somsen GW; Department of Chemistry and Pharmaceutical Sciences, Amsterdam Institute of Molecular and Life Sciences (AIMMS), Division of BioAnalytical Chemistry, Vrije Universiteit Amsterdam, De Boelelaan 1085, 1081 HV Amsterdam, The Netherlands.; Centre of Analytical Sciences Amsterdam (CASA), Science Park 904, 1098 XH Amsterdam, The Netherlands.
Jazyk: angličtina
Zdroj: Analytical chemistry [Anal Chem] 2023 Dec 26; Vol. 95 (51), pp. 18767-18775. Date of Electronic Publication: 2023 Dec 13.
DOI: 10.1021/acs.analchem.3c03356
Abstrakt: Analytical methods for the assessment of drug-delivery systems (DDSs) are commonly suitable for characterizing individual DDS properties, but do not allow determination of several properties simultaneously. A comprehensive online two-dimensional liquid chromatography (LC × LC) system was developed that is aimed to be capable of characterizing both nanoparticle size and encapsulated cargo over the particle size distribution of a DDS by using one integrated method. Polymeric nanoparticles (NPs) with encapsulated hydrophobic dyes were used as model DDSs. Hydrodynamic chromatography (HDC) was used in the first dimension to separate the intact NPs and to determine the particle size distribution. Fractions from the first dimension were taken comprehensively and disassembled online by the addition of an organic solvent, thereby releasing the encapsulated cargo. Reversed-phase liquid chromatography (RPLC) was used as a second dimension to separate the released dyes. Conditions were optimized to ensure the complete disassembly of the NPs and the dissolution of the dyes during the solvent modulation step. Subsequently, stationary-phase-assisted modulation (SPAM) was applied for trapping and preconcentration of the analytes, thereby minimizing the risk of analyte precipitation or breakthrough. The developed HDC × RPLC method allows for the characterization of encapsulated cargo as a function of intact nanoparticle size and shows potential for the analysis of API stability.
Databáze: MEDLINE