Quality Control of Powdered Metformin Using Hyperspectral Imaging and Machine Learning Models

Document Type : Original Article

Authors

Department of Chemistry, Sharif University of Technology, Tehran, Iran

Abstract

Given the global growth in the production and consumption of generic drugs and the increasing risk of counterfeit or substandard pharmaceutical products, the development of novel, rapid, and non-destructive quality control methods has become critically important. In this study, hyperspectral imaging (HSI) in the visible to near-infrared range (Vis-NIR, 400–950 nm), combined with chemometric/machine learning techniques, was employed to assess the active pharmaceutical ingredient (API) content of metformin in powder-based samples. Samples were classified into three dosage groups: standard dose (SD), low non-standard dose (LD), and high non-standard dose (HD). Hyperspectral imaging data were processed using spectral averaging, principal component analysis (PCA), partial least squares-discriminant analysis (PLS-DA), and machine learning algorithms including artificial neural network (ANN) and support vector machines (SVM). Results demonstrated that chemometric models, particularly ANN and PLS-DA, could effectively differentiate between the three sample groups with high accuracy. The combination of Vis-NIR HSI and statistical modelling proved to be a powerful tool for detecting metformin dosage levels and distinguishing standard from non-standard pharmaceutical compositions.

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