Screening of nanoemulsion components for asenapine maleate using validated RP-HPLC method.
Calibration
Chromatography, High Pressure Liquid
Chromatography, Reverse-Phase
Dibenzocycloheptenes
/ analysis
Drug Compounding
Emulsions
/ analysis
Indicators and Reagents
Limit of Detection
Nanostructures
/ analysis
Oils
Particle Size
Reference Standards
Reproducibility of Results
Sensitivity and Specificity
Spectrophotometry, Ultraviolet
Surface-Active Agents
Asenapine maleate
Nanoemulsion
Pre-formulation study
RP-HPLC
Sensitive method
Validation
Journal
Annales pharmaceutiques francaises
ISSN: 0003-4509
Titre abrégé: Ann Pharm Fr
Pays: France
ID NLM: 2985176R
Informations de publication
Date de publication:
Sep 2020
Sep 2020
Historique:
received:
11
02
2020
revised:
26
04
2020
accepted:
27
04
2020
pubmed:
11
5
2020
medline:
22
6
2021
entrez:
11
5
2020
Statut:
ppublish
Résumé
A novel, simple reversed-phase high-performance liquid chromatographic (RP-HPLC) analytical method was developed and validated for the quantitative determination of asenapine from various nanoemulsion components during pre-formulation screening. The developed method was validated according to ICH Q2 (R1) guidelines. The developed and validated method was precisely and accurately quantified asenapine in various oils, surfactants and co-surfactants. The separation of asenapine was carried out on Hypersil BDS C18, 250×4.6mm, 5μm particle size column using methanol: acetonitrile (90:10) as mobile phase with a flow rate of 1mL.min
Identifiants
pubmed: 32387177
pii: S0003-4509(20)30053-5
doi: 10.1016/j.pharma.2020.04.005
pii:
doi:
Substances chimiques
Dibenzocycloheptenes
0
Emulsions
0
Indicators and Reagents
0
Oils
0
Surface-Active Agents
0
asenapine
JKZ19V908O
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
379-387Informations de copyright
Copyright © 2020 Académie Nationale de Pharmacie. Published by Elsevier Masson SAS. All rights reserved.