doiSerbia

The application of NIR spectroscopy with chemometric analysis for monitoring the powder blending process

Marić Ljiljana B. (Galenika ad, Belgrade)
Jović Branislav D. (Galenika ad, Belgrade)
Petrović Slobodan D. (Galenika ad, Belgrade)
Nikolić Aleksandar M. (Galenika ad, Belgrade)
Homšek Irena J. (Galenika ad, Belgrade)

This paper reports the use of Near Infrared (NIR) spectroscopy as a Process Analytical Technology (PAT) tool for monitoring the metformin hydrochloride and polyvinilpyrolidone (PVP) mixing process, which is the first stage in the tablet production. Blend homogeneity was tested using the noninvasive NIR spectroscopy method and Partial Least Squares (PLS) regression model was applied for the analysis of the obtained spectra. Simultaneously, the critical parameter (metformin hydrochloride content) was monitored by classical analytical technique, validated HPLC method, commonly used for this purpose. Based on the high sensitivity of the model developed in this study, as well as the established correlation among the results obtained by different methods, it can be concluded that the proposed rapid and noninvasive technique can be an effective tool for one of the critical manufacturing step monitoring in solid dosage forms production.

Keywords: PAT, NIR spectroscopy, PLS, metformin hydrochloride, blend uniformity analysis