Validation of an in-line Raman spectroscopic method for continuous active pharmaceutical ingredient quantification during pharmaceutical hot-melt extrusion

Analytica Chimica Acta
L SaerensT R M De Beer

Abstract

A calibration model for in-line API determination was developed based on Raman spectra collected during hot-melt extrusion. This predictive model was validated by calculating the accuracy profile based on the analysis results of validation experiments. Furthermore, based on the data of the accuracy profile, the measurement uncertainty was determined. Finally, the robustness of the model was evaluated. A Raman probe was implemented in the die of a twin-screw extruder, to monitor the drug concentration during extrusion of physical mixtures containing 15, 20, 25, 30 and 35% (w/w) metoprolol tartrate (MPT) in Eudragit(®) RS PO, an amorphous copolymer of acrylic and methacrylic acid esters with a low content of quaternary ammonium groups, which are present as salts. Several different calibration models for the prediction of the MPT content were developed, based on the use of single spectra or averaged spectra, and using partial least squares (PLS) regression or multivariate curve resolution (MCR). These predictive models were validated by extruding and monitoring mixtures containing 17.5, 22.5, 25.0, 27.5 and 32.5% (w/w) MPT. Each validated concentration was monitored on three different days, by two different operators. The β-expect...Continue Reading

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Citations

Jan 13, 2018·Drug Delivery and Translational Research·Jens WesholowskiMarkus Thommes
Mar 28, 2017·Analytical and Bioanalytical Chemistry·Patrick HitzerKarsten Rebner
Aug 16, 2016·Analytical and Bioanalytical Chemistry·Francisca F GouveiaMichael J Mealy
Apr 3, 2021·International Journal of Pharmaceutics·Maryam Karimi-JafariGavin Walker
May 25, 2021·Advanced Drug Delivery Reviews·Chloé ParulskiBrigitte Evrard

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