Prediction of Dissolution Profile of Marketed Paracetamol Tablets by Non-Destructive Near-Infrared Spectroscopy

Aim and Objective: This study aims to evaluate the efficacy of near-infrared (NIR) spectroscopy in predicting dissolution profiles of six different brands of Paracetamol tablets (500mg) selected based on their prevalence in the local market, considering their higher sales and widespread availability within the geographical area of study. The primary objective of this research work is to establish a robust correlation between the spectral data acquired through NIR spectroscopy and the in-vitro dissolution profiles of these tablets, exploring its potential as a predictive tool. Methodology: The study employs Partial Least Square Regression (PLSR) to obtain distinctive spectral data from Paracetamol tablets using NIR spectroscopy. In vitro dissolution studies are performed to determine the dissolution profiles of the different branded tablets (3 Branded and 3 Generic versions). The collected spectral data is then associated with the dissolution datas using PLSR to create a predictive model. Results and Discussion: The analysis shows a significant relationship between the NIR spectral data and the dissolution values of the Paracetamol tablets. Conclusion: The dissolution analysis revealed strong predictive correlations in branded (A, B, C) and generic (D, E, F) tablet batches. While branded tablets consistently displayed high prediction accuracy, generic versions showcased promising predictive capabilities, warranting minor refinements for improved validation accuracy.