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

• Published in: Journal of the Serbian Chemical Society Vol. 79; no. 3; pp. 331 - 340
• Main Authors: Maric, Ljiljana, Jovic, Branislav, Petrovic, Slobodan, Nikolic, Aleksandar, Homsek, Irena
• Format: Journal Article
• Language: English
• Published: Belgrade Journal of the Serbian Chemical Society 2014; Serbian Chemical Society
• Subjects: blend uniformity analysis; Correlation analysis; Infrared analysis; Infrared imaging systems; Metformin; metformin hydrochloride; Monitoring; Near infrared radiation; NIR spectroscopy; PAT; PLS; Powder blending; Regression analysis; Regression models; Spectroscopic analysis; Spectrum analysis; Technology assessment
• ISSN: 0352-5139; 1820-7421
• DOI: 10.2298/JSC010413080M

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. nema PR Projekat Ministarstva nauke Republike Srbije, br. 172013 i br. TR 34007