Reference : Analytical quality by design: development and control strategy for a LC method to eva...
Scientific journals : Article
Human health sciences : Pharmacy, pharmacology & toxicology
http://hdl.handle.net/2268/232145
Analytical quality by design: development and control strategy for a LC method to evaluate the cannabinoids content in cannabis olive oil extracts
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 >]
Baronti, Roberto mailto [Azienda USL Toscana centro - > Laboratory of Clinical Toxicology and Antidoping, Via di San Salvi 12, 50135 Florence, Italy > > >]
Davolio, Pier Luigi mailto [Farmacia del Madonnone, Via Aretina 9r, 50135 Florence, Italy > > > >]
Pasquini, Benedetta mailto [Università degli Studi di Firenze - UniFI > Department of Chemistry “U. Schiff”, Via U. Schiff 6, 50019 Sesto Fiorentino, Florence, Italy > > >]
Del Bubba, Massimo mailto [Università degli Studi di Firenze - UniFI > Department of Chemistry “U. Schiff”, Via U. Schiff 6, 50019 Sesto Fiorentino, Florence, Italy > > >]
Hubert, Cédric mailto [Université de Liège - ULiège > Département de pharmacie > Chimie analytique >]
Hubert, Philippe mailto [Université de Liège - ULiège > Département de pharmacie > Chimie analytique >]
Orlandini, Serena mailto [Università degli Studi di Firenze - UniFI > Department of Chemistry “U. Schiff”, Via U. Schiff 6, 50019 Sesto Fiorentino, Florence, Italy > > >]
Furlanetto, Sandra mailto [Università degli Studi di Firenze - UniFI > Department of Chemistry “U. Schiff”, Via U. Schiff 6, 50019 Sesto Fiorentino, Florence, Italy > > >]
21-Jan-2019
Journal of Pharmaceutical and Biomedical Analysis
Elsevier
Yes (verified by ORBi)
International
0731-7085
1873-264X
[en] cannabinoids ; quality by design ; Cannabis sativa ; HPLC ; olive oil extracts ; control strategy
[en] Cannabidiol (CBD) and Δ9-tetrahydrocannabinol (Δ9-THC) are considered as the most interesting cannabinoids in Cannabis sativa L. for the clinical practice. Since 2013, the Italian law allows pharmacists to prepare and dispense cannabis extracts to patients under medical prescription, and requires the evaluation of CBD and Δ9-THC content in cannabis extracts before sale. Cannabis olive oil extracts are prepared from dried female cannabis inflorescences, but a standard protocol is still missing. In this study, a fast RP-HPLC/UV method has been developed to quantify CBD and Δ9-THC in cannabis olive oil extracts. The analytical quality by design strategy has been applied to the method development, setting critical resolution and total analysis time as critical method attributes (CMAs), and selecting column temperature, buffer pH and flow rate as critical method parameters. Information from Doehlert Design in response surface methodology combined to Monte-Carlo simulations led to draw the risk of failure maps and to identify the method operable design region. The method was validated according to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines and then implemented in routine analysis. A control strategy based on system control charts was planned to monitor the developed method performances. Evaluation data were recorded over a period of one year of routine use, and both the CMAs showed values within the specifications in every analysis performed. Hence, a new risk evaluation for the future performances of the method was achieved by using a Bayesian approach based on the routine use data, computing the future distribution of the two CMAs. Finally, a study focusing on the monitoring of CBD and Δ9-THC concentrations in cannabis olive oil extracts was carried out. The developed method was applied to 459 extracts. The statistical analysis of the obtained results highlighted a wide variability in terms of concentrations among different samples from the same starting typology of cannabis, underlining the compelling need of a standardised procedure to harmonise the preparation of the extracts.
Researchers ; Professionals ; Students
http://hdl.handle.net/2268/232145
10.1016/j.jpba.2019.01.032
https://doi.org/10.1016/j.jpba.2019.01.032

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