Advanced chemometric methods as powerful tools for impurity profiling of drug substances and drug products: Application on bisoprolol and perindopril binary mixture.

Autor: Hassan SA; Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Kasr El-Aini street, Cairo 11562, Egypt; Analytical Chemistry Department, Faculty of Pharmacy, Misr University for Science & Technology, Al-Motamayez District, P.O. Box 77, 6th of October City, Egypt. Electronic address: said.hassan@pharma.cu.edu.eg., Nashat NW; Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Kasr El-Aini street, Cairo 11562, Egypt., Elghobashy MR; Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Kasr El-Aini street, Cairo 11562, Egypt; October 6 University, Faculty of Pharmacy, October 6 city, Giza, Egypt., Abbas SS; Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Kasr El-Aini street, Cairo 11562, Egypt., Moustafa AA; Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Kasr El-Aini street, Cairo 11562, Egypt.
Jazyk: angličtina
Zdroj: Spectrochimica acta. Part A, Molecular and biomolecular spectroscopy [Spectrochim Acta A Mol Biomol Spectrosc] 2022 Feb 15; Vol. 267 (Pt 2), pp. 120576. Date of Electronic Publication: 2021 Nov 02.
DOI: 10.1016/j.saa.2021.120576
Abstrakt: Impurity profiling has a rising importance nowadays due to the increased health problems associated with impurities and degradation products found in several drug substances and formulations. Three advanced, accurate and precise chemometric methods were developed as impurity profiling methods for a mixture of bisoprolol fumarate (BIS) and perindopril arginine (PER) with their degradation products which represent drug impurity or a precursor to such impurity. The methods applied were Partial Least Squares (PLS-1), Multivariate Curve Resolution-Alternating Least Squares (MCR-ALS) and Artificial Neural Networks (ANN). Genetic Algorithm (GA) was used as a variable selection tool to select the most significant wavelengths for the three chemometric models. For proper analysis, a 5-factor 5-level experimental design was used to establish a calibration set of 25 mixtures containing different ratios of the drugs and their degradation products (impurities). The validity of the proposed methods was assessed using an independent validation set. The designed models were able to predict the concentrations of the drugs and the degradation products/impurities in the validation set and pharmaceutical formulation. The proposed methods presented a powerful alternative to traditional and expensive chromatographic methods as impurity profiling tools.
Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
(Copyright © 2021. Published by Elsevier B.V.)
Databáze: MEDLINE
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