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Computer-assisted UHPLC–MS method development and optimization for the determination of 24 antineoplastic drugs used in hospital pharmacy

Publié dansJournal of Pharmaceutical and Biomedical Analysis, vol. 164, p. 395-401
Date de publication2019
Résumé

This study reports the use of retention modeling software for the successful method development of 24 injectable antineoplastic agents. Firstly, a generic screening of several stationary and mobile phases (using various organic modifiers and pH) was achieved. Then, an optimization procedure of mobile phase temperature, gradient profile and mobile phase binary composition was conducted through only 28 real experiments using retention modeling software for data treatment. Finally, the optimized separation was achieved with a mobile phase consisting in 10 mM acetic acid at pH 5.1 (A) and acetonitrile (B). A Waters CORTECS® T3 column (100 × 2.1 mm, 1.6 µm) operated at 25 °C with a gradient time of 17.5 min (0-51%B) at a flow rate of 0.4 mL/min was used. The prediction offered by the retention model was found to be highly reliable, with an average error lower than 1%. A robustness testing step was also assessed from a virtual experimental design. Success rate and regression coefficient were evaluated without the need to perform any real experiment. The developed LC-MS method was successfully applied to the analysis of pharmaceutical formulations and wiping samples from working environment.

Mots-clés
  • Antineoplastic agent
  • Drylab®
  • Method development
  • Retention modeling
  • Reversed phase liquid chromatography
Citation (format ISO)
GUICHARD, Nicolas et al. Computer-assisted UHPLC–MS method development and optimization for the determination of 24 antineoplastic drugs used in hospital pharmacy. In: Journal of Pharmaceutical and Biomedical Analysis, 2019, vol. 164, p. 395–401. doi: 10.1016/j.jpba.2018.11.014
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Article (Published version)
accessLevelRestricted
Identifiants
ISSN du journal0731-7085
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Informations techniques

Création01/02/2019 11:03:00
Première validation01/02/2019 11:03:00
Heure de mise à jour15/03/2023 15:39:46
Changement de statut15/03/2023 15:39:45
Dernière indexation17/01/2024 04:48:48
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