The development and validation of a quality by design based process analytical tool for the inline quantification of Ramipril during hot-melt extrusion.

•HME was successfully used for the manufacture of Ramipril drug product.•The established design space showed good predictability for Ramipril content.•A PLS calibration model was developed using the collected inline Raman spectra.•The PLS model can describe more than 98.9% of the variance observed in the calibration set.•The model can predict the unknowns with less than ±7% deviation from the mean value.