Reference : Control strategy applied to a LC-DAD quality control method as part of the analytical...
Scientific conferences in universities or research centers : Scientific conference in universities or research centers
Human health sciences : Pharmacy, pharmacology & toxicology
http://hdl.handle.net/2268/231898
Control strategy applied to a LC-DAD quality control method as part of the analytical quality by design approach: one year of routine use
English
Deidda, Riccardo mailto [Université de Liège - ULiège > Département de pharmacie > Chimie analytique >]
Avohou, Tonakpon Hermane mailto [Université de Liège - ULiège > Département de pharmacie > Chimie analytique >]
Orlandini, Serena mailto [Università degli Studi di Firenze - UniFI > Department of Chemistry "U. Schiff" > > >]
Baronti, Roberto mailto [Azienda USL Toscana Centro > Clinical Toxicology and Anti-Doping Laboratory > > >]
Pasquini, Benedetta mailto [Università degli Studi di Firenze - UniFI > Department of Chemistry "U. Schiff" > > >]
Furlanetto, Sandra mailto [Università degli Studi di Firenze - UniFI > Department of Chemistry "U. Schiff" > > >]
Hubert, Philippe mailto [Université de Liège - ULiège > Département de pharmacie > Chimie analytique >]
Hubert, Cédric mailto [Université de Liège - ULiège > Département de pharmacie > Chimie analytique >]
19-Dec-2018
International
1st CIRM Scientific Day
19-12-2018
CIRM
Liège
Belgium
[en] analytical quality by design ; control strategy ; LC-DAD
[en] The analytical quality by design approach has been previously applied to the method development. The analytical target profile (ATP) was defined as the baseline separation of the two analytes of interest, cannabidiol and Δ9-tetrahydrocannabinol. The critical method attributes (CMAs) were set as the critical resolution between a peak pair (Rs) and the analysis time (t). Critical method parameters were studied, and the response surface methodology was used to optimise the method. The method operable design region (MODR) was obtained by Monte-Carlo simulations and risk of failure maps setting the probability of meeting the specifications (Rs ≥ 0.85 and t ≤ 6 min) at 95%. A working point within the MODR was chosen, validated, and implemented in routine analyses. The information collected during the optimisation studies was conveyed to the planning of the control strategy consisting in system suitability test and control charts. The CMAs used for method optimisation were chosen as system suitability criteria to monitor the behaviour of the method performance. The evaluation was conducted over a period of one year of routine use. Both the CMAs showed values within the specifications in each analysis performed. On the basis of these results, a new and more complete risk evaluation was achieved.
Laboratory of Pharmaceutical Analytical Chemistry - Prof. Philippe Hubert
Researchers ; Professionals ; Students
http://hdl.handle.net/2268/231898

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