Chemometric-Assisted ATR-FTIR Spectroscopy for Rapid Authentication and Quality Evaluation of Marketed Antidiabetic Tablet Formulations

Background

The widespread availability of branded and generic antidiabetic tablet formulations has increased the need for rapid, reliable, and cost-effective analytical methods to ensure their authenticity and quality. Conventional quality evaluation techniques are often time-consuming, destructive, and require extensive sample preparation. Chemometric-Assisted Attenuated total Reflectance Fourier Transform Infrared (ATR-FTIR) spectroscopy offers a rapid, non-destructive, and environmentally friendly approach for the authentication and quality assessment of pharmaceutical formulations.

Objectives

The present study aimed to develop a rapid, non-destructive, and environmentally sustainable analytical approach for the authentication and quality evaluation of marketed antidiabetic tablet formulations using ATR-FTIR spectroscopy coupled with chemometric techniques.

Materials and Methods

Commercially available branded and generic formulations containing vildagliptin and metformin, teneligliptin and metformin, and dapagliflozin and metformin combinations were analyzed. ATR-FTIR spectra were acquired over the range of 4000-400 cm⁻¹ and subjected to spectral preprocessing including baseline correction, Savitzky-Golay smoothing, standard normal variate transformation, normalization, derivative processing, and mean centering. Principal Component Analysis (PCA), Hierarchical Cluster Analysis (HCA), and Partial Least Squares-Discriminant Analysis (PLS-DA) were employed for classification and authentication of formulations.

Results

PCA demonstrated effective discrimination among formulations, with cumulative variances of 93.5%, 79.5%, and 94.3% for vildagliptin and metformin, teneligliptin and metformin, and dapagliflozin and metformin products, respectively. HCA generated distinct clustering patterns corresponding to branded and generic products, particularly for vildagliptin and metformin formulations. PLS-DA models exhibited excellent classification performance with high accuracy, sensitivity, and specificity.

Conclusion

The findings indicate that ATR-FTIR spectroscopy combined with chemometric modeling provides a rapid, cost-effective, and green analytical platform for pharmaceutical authentication and quality assessment. The developed approach may serve as a reliable alternative to conventional chromatographic techniques for routine quality control and counterfeit detection.