A green TLC densitometric method for the simultaneous detection and quantification of naphazoline HCl, pheniramine maleate along with three official impurities.
EHS tool
Impurities
Naphazoline
Pheniramine
TLC
Journal
BMC chemistry
ISSN: 2661-801X
Titre abrégé: BMC Chem
Pays: Switzerland
ID NLM: 101741142
Informations de publication
Date de publication:
04 Apr 2022
04 Apr 2022
Historique:
received:
06
02
2022
accepted:
25
03
2022
entrez:
5
4
2022
pubmed:
6
4
2022
medline:
6
4
2022
Statut:
epublish
Résumé
Impurity profiling of a pharmaceutical compound is now taking great attention during quality assessment of pharmaceuticals, as presence of small amount of impurities may affect safety and efficacy. In this work, a novel TLC chromatographic method coupled with densitometric detection was established for the simultaneous quantification of naphazoline HCl, pheniramine maleate and three of their official impurities, namely; naphazoline impurity B, pheniramine impurities; A & B. Chromatographic separation was carried out on TLC aluminum silica plates F254, as a stationary phase, using methanol: ethyl acetate: 33.0% ammonia (2.0: 8.0: 1.0, by volume), as a mobile phase. Plates were examined at 260.0 nm and International Council for Harmonisation (ICH) guidelines were followed for method's validation. Important factors, such as; composition of mobile phase and detection wavelengths were optimized. Linearity was achieved over the ranges of 2.0-50.0 µg band
Identifiants
pubmed: 35379288
doi: 10.1186/s13065-022-00819-9
pii: 10.1186/s13065-022-00819-9
pmc: PMC8981625
doi:
Types de publication
Journal Article
Langues
eng
Pagination
24Informations de copyright
© 2022. The Author(s).
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