Reference : Global approach for the validation of an in-line Raman spectroscopic method to determ...
Scientific journals : Article
Human health sciences : Pharmacy, pharmacology & toxicology
http://hdl.handle.net/2268/209929
Global approach for the validation of an in-line Raman spectroscopic method to determine the API content in real-time during a hot-melt extrusion process
English
Netchacovitch, Lauranne mailto [Université de Liège > Département de pharmacie > Chimie analytique >]
Thiry, Justine mailto [Université de Liège > Département de pharmacie > Pharmacie galénique >]
De Bleye, Charlotte mailto [Université de Liège > Département de pharmacie > Département de pharmacie >]
Dumont, Elodie mailto [Université de Liège > Département de pharmacie > Chimie analytique >]
Cailletaud, Johan mailto [Université de Liège > Département de pharmacie > Chimie analytique >]
Sacre, Pierre-Yves mailto [Université de Liège > Département de pharmacie > Chimie analytique >]
Evrard, Brigitte mailto [Université de Liège > Département de pharmacie > Pharmacie galénique >]
Hubert, Philippe mailto [Université de Liège > Département de pharmacie > Chimie analytique >]
Ziemons, Eric mailto [Université de Liège > Département de pharmacie > Département de pharmacie >]
26-Apr-2017
Talanta
Elsevier Science
171
45-52
Yes (verified by ORBi)
International
0039-9140
1873-3573
Amsterdam
The Netherlands
[en] In-line validation ; Real-time analysis ; Raman spectroscopy ; Hot-Melt Extrusion ; API content ; Accuracy profile
[en] Since the Food and Drug Administration (FDA) published a guidance based on the Process Analytical Technology (PAT) approach, real-time analyses during manufacturing processes are in real expansion.
In this study, in-line Raman spectroscopic analyses were performed during a Hot-Melt Extrusion (HME) process to determine the Active Pharmaceutical Ingredient (API) content in real-time. The method was validated based on a univariate and a multivariate approach and the analytical performances of the obtained models were compared. Moreover, on one hand, in-line data were correlated with the real API concentration present in the sample quantified by a previously validated off-line confocal Raman microspectroscopic method. On the other hand, in-line data were also treated in function of the concentration based on the weighing of the components in the prepared mixture. The importance of developing quantitative methods based on the use of a reference method was thus highlighted. The method was validated according to the total error approach fixing the acceptance limits at ± 15% and the α risk at ± 5%. This method reaches the requirements of the European Pharmacopeia norms for the uniformity of content of single-dose preparations. The validation proves that future results will be in the acceptance limits with a previously defined probability.
Finally, the in-line validated method was compared with the off-line one to demonstrate its ability to be used in routine analyses.
Centre Interfacultaire de Recherche du Médicament - CIRM
Researchers ; Professionals ; Students
http://hdl.handle.net/2268/209929
10.1016/j.talanta.2017.04.060

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