Review of the article „A Comparative Chemometric Study for Quantitative Determination of Duloxetine Hydrochloride in presence of its Toxic Impurity 1-Naphthol“, verified by Publons, Web of Science

Abstract

Abstract: Three multivariate chemometric models, called classical least squares (CLS), partial least-squares (PLS) and linear support vector regression (SVR), are developed for the quantitative determination of Duloxetine Hydrochloride (DUL) in presence of its toxic impurity (1-naphthol) in raw materials and pharmaceutical dosage form by using UV spectral data. The three methods are compared among each other and the advantages and disadvantages are discussed. For good results, a two-factor, a four-level experimental design was used, resulting in a training set of 16 mixtures containing different ratios of each component. The test set consisting of nine mixtures was necessary to test the ability of the proposed methods to predict DUL in presence of its impurity 1-naphthol. The results show the success of the three developed methods to determine DUL in presence of small levels of its toxic impurity with good accuracy and selectivity. The results of the dosage form were compared statistically to that of the reported HPLC method, with no significant difference in accuracy and precision, indicating that the suggested calibration models are able and suitable for routine analysis of the drug in bulk and pharmaceutical dosage forms. Compared to the CLS and PLS models, the SVR model gives the best results regarding to the accuracy with a lower prediction error and better generalization ability. However, the CLS and PLS models are found to be simpler and faster in usage and management.