An ultra-high-performance chromatography ...
Type de document :
Article dans une revue scientifique: Article de synthèse/Review paper
PMID :
URL permanente :
Titre :
An ultra-high-performance chromatography method to study the long term stability of gemcitabine in dose banding conditions
Auteur(s) :
Closset, Melanie [Auteur]
CHU UCL Namur
Colsoul, Marie-Lise [Auteur]
CHU UCL Namur
Goderniaux, Nicolas [Auteur]
CHU UCL Namur
Bihin, Benoît [Auteur]
CHU UCL Namur
Jamart, Jacques [Auteur]
CHU UCL Namur
Onorati, Sabrina [Auteur]
CHU UCL Namur
Soumoy, Laura [Auteur]
CHU UCL Namur
Hecq, Jean-Daniel [Auteur]
CHU UCL Namur
Odou, Pascal [Auteur]
Groupe de Recherche sur les formes Injectables et les Technologies Associées (GRITA) - ULR 7365
Galanti, Laurence [Auteur]
CHU UCL Namur
CHU UCL Namur
Colsoul, Marie-Lise [Auteur]
CHU UCL Namur
Goderniaux, Nicolas [Auteur]
CHU UCL Namur
Bihin, Benoît [Auteur]
CHU UCL Namur
Jamart, Jacques [Auteur]
CHU UCL Namur
Onorati, Sabrina [Auteur]
CHU UCL Namur
Soumoy, Laura [Auteur]
CHU UCL Namur
Hecq, Jean-Daniel [Auteur]
CHU UCL Namur
Odou, Pascal [Auteur]
Groupe de Recherche sur les formes Injectables et les Technologies Associées (GRITA) - ULR 7365
Galanti, Laurence [Auteur]
CHU UCL Namur
Titre de la revue :
Journal of Pharmaceutical and Biomedical Analysis
Nom court de la revue :
J Pharm Biomed Anal
Numéro :
227
Pagination :
115290
Éditeur :
Elsevier
Date de publication :
2023-04-01
ISSN :
1873-264X
Discipline(s) HAL :
Sciences du Vivant [q-bio]
Résumé en anglais : [en]
Gemcitabine is an analogue of cytidine arabinoside, used alone or in combination chemotherapy to treat various type of cancer. The dose-banding of gemcitabine provides the opportunity to anticipate the preparation of this ...
Lire la suite >Gemcitabine is an analogue of cytidine arabinoside, used alone or in combination chemotherapy to treat various type of cancer. The dose-banding of gemcitabine provides the opportunity to anticipate the preparation of this anticancer drug on condition of carrying out stability studies. The aim of this study is to develop and validate a stability-indicating ultra-high-performance Liquid Chromatography (UHPLC) method for measuring the concentration of gemcitabine and to evaluate its stability at standardised rounded doses in polyolefin bags. The UHPLC with photodiode array (PDA) detector method was developed and validated (linearity, precision, accuracy, limits of detection and quantification, robustness and degradation test). Thirty polyolefin bags of gemcitabine (1600 mg/292 ml (n = 10), 1800 mg/297 ml (n = 10) and 2000 mg/303 ml (n = 10)) were prepared under aseptic conditions and stored at 5 ± 3 °C and 23 ± 2 °C for 49 days. Physical stability tests were periodically performed: visual and microscopic inspection and optical densities. The chemical stability was evaluated through pH monitoring and chromatographic assays. The results confirm the stability of Gemcitabine at selected standardised rounded doses of 1600 mg, 1800 mg and 2000 mg in NaCl 0.9% polyolefin bags for at least 49 days at 5 ± 3 °C and 23 ± 2 °C, allowing in-advance preparation.Lire moins >
Lire la suite >Gemcitabine is an analogue of cytidine arabinoside, used alone or in combination chemotherapy to treat various type of cancer. The dose-banding of gemcitabine provides the opportunity to anticipate the preparation of this anticancer drug on condition of carrying out stability studies. The aim of this study is to develop and validate a stability-indicating ultra-high-performance Liquid Chromatography (UHPLC) method for measuring the concentration of gemcitabine and to evaluate its stability at standardised rounded doses in polyolefin bags. The UHPLC with photodiode array (PDA) detector method was developed and validated (linearity, precision, accuracy, limits of detection and quantification, robustness and degradation test). Thirty polyolefin bags of gemcitabine (1600 mg/292 ml (n = 10), 1800 mg/297 ml (n = 10) and 2000 mg/303 ml (n = 10)) were prepared under aseptic conditions and stored at 5 ± 3 °C and 23 ± 2 °C for 49 days. Physical stability tests were periodically performed: visual and microscopic inspection and optical densities. The chemical stability was evaluated through pH monitoring and chromatographic assays. The results confirm the stability of Gemcitabine at selected standardised rounded doses of 1600 mg, 1800 mg and 2000 mg in NaCl 0.9% polyolefin bags for at least 49 days at 5 ± 3 °C and 23 ± 2 °C, allowing in-advance preparation.Lire moins >
Langue :
Anglais
Audience :
Internationale
Vulgarisation :
Non
Établissement(s) :
Université de Lille
CHU Lille
CHU Lille
Collections :
Équipe(s) de recherche :
Modélisation biopharmaceutique et pharmacocinétique
Date de dépôt :
2023-05-25T02:16:23Z
2023-10-03T09:51:55Z
2023-10-03T09:51:55Z