Development of an ultra-high-performance liquid chromatography-charged aerosol detection/UV method for the quantitation of linear polyethylenimines in oligonucleotide polyplexes.
J Sep Sci
; 43(20): 3876-3884, 2020 Oct.
Article
en En
| MEDLINE
| ID: mdl-32786026
ABSTRACT
Linear polyethylenimines are polycationic excipients that have found many pharmaceutical applications, including as a delivery vehicle for gene therapy through formation of polyplexes with oligonucleotides. Accurate quantitation of linear polyethylenimines in both starting solution and formulation containing oligonucleotide/polyethylenimine polyplexes is critical. Existing methods using spectroscopy, matrix-assisted laser desorption/ionization mass spectrometry time-of-flight, or nuclear magnetic resonance are either complex or suffer from low selectivity. Here, the development and performance of a simple analytical method is described whereby linear polyethylenimines are resolved by ultra-high-performance liquid chromatography and quantified using either a charged aerosol detector or an ultraviolet detector. For formulated oligonucleotide/polyethylenimine polyplexes, sample preparation through decomplexation/digestion by trifluoroacetic acid was necessary to eliminate separation interference. The method can be used not only to support formulation development but also to monitor the synthesis/purification and characterization of linear polyethylenimines.
Palabras clave
Texto completo:
1
Bases de datos:
MEDLINE
Asunto principal:
Oligonucleótidos
/
Polietileneimina
Tipo de estudio:
Diagnostic_studies
Idioma:
En
Revista:
J Sep Sci
Año:
2020
Tipo del documento:
Article
País de afiliación:
Estados Unidos