Application of high-performance, thin-layer chromatography to quality control of antimetabolite analogue infusion bags

A global postproduction quality program was developed to secure chemotherapy infusion at the Gustave Roussy Institute. Despite rigorous procedures and computerized prescriptions, an analytical check was necessary to improve the quality of ready-to-use solutions of cytotoxic drugs in our Centralized...

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Bibliographic Details
Published in:Journal of AOAC International 2001-07, Vol.84 (4), p.1296-1300
Main Authors: Perello, L, Demirdjian, S, Dory, A, Bourget, P
Format: Article
Language:English
Subjects:
Antimetabolites, Antineoplastic - administration & dosage
Antimetabolites, Antineoplastic - analysis
Chromatography, Thin Layer
Humans
Infusions, Intravenous
Quality Control
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Summary:A global postproduction quality program was developed to secure chemotherapy infusion at the Gustave Roussy Institute. Despite rigorous procedures and computerized prescriptions, an analytical check was necessary to improve the quality of ready-to-use solutions of cytotoxic drugs in our Centralized Antineoplastics Reconstitution Unit. High-performance, thin-layer chromatography was selected as the analytical tool to assay 12 anticancer drugs. One of the analytical methods can separate 4 antimetabolite substances, i.e., fludarabine (FDB), cytarabine (CTB), gemcitabine (GTB), and fluorouracil (5 FU). For all infusion bags manufactured, up to 26 samples could be assayed per series using a double standard calibration (GTB and 5 FU).
ISSN:1060-3271
1944-7922
DOI:10.1093/jaoac/84.4.1296