Design and validation of eco-friendly chemometric-assisted spectrophotometric methods for the simultaneous determination of chlorzoxazone, paracetamol, and aceclofenac in the presence of their main impurities

Ayoub N. Mozayad, Pharmaceutical Chemistry Department, Faculty of Pharmacy, Sana’a University,1247, Sana’a, YemenFollow
Marwa A. Fouad, Pharmaceutical Chemistry Department, Faculty of Pharmacy, Cairo University, Kasr El-Aini Street, 11562 Cairo, Egypt
Ehab F. Elkady, Pharmaceutical Chemistry Department, Faculty of Pharmacy, Cairo University, Kasr El-Aini Street, 11562 Cairo, Egypt

Subject Area

General Chemistry

Abstract

Objective: The goal of this work is to develop and validate eco-friendly spectrophotometric methods for the simultaneous determination of chlorzoxazone (CHZ), paracetamol (PAR), and aceclofenac (ACF) in the presence of their major impurities, specifically 2-amino-4-chlorophenol (ACP), 4-aminophenol (4-AP), and diclofenac (DCF), in commercially available tablet dosage forms using chemometric techniques. Method: Six chemometric models, namely classical least squares (CLS), partial least squares (PLS) regression, and principal component regression (PCR), in addition to feed-forward back-propagation artificial neural networks (FFBP-ANN), cascade-forward back-propagation artificial neural networks (CFBP-ANN), and radial basis function artificial neural networks (RBF-ANN), were employed to analyze the synthetic mixtures, which included the cited drugs and their main impurities and degradation products, using phosphate buffer solution (pH 7.0) as the green solvent. A validation set of seven mixtures in the wavelength range of 260–302.4 nm at 0.1 nm intervals was used to validate the suggested models after they had been constructed with a calibration set of twelve mixtures. Results: The proposed multivariate calibration methods exhibited good linear relationships in accordance with the Beer-Lambert law, spanning concentration ranges of 6–19 µg mL−1 for CHZ, 8.45–24.05 µg mL−1 for PAR, and 2.4-7.6 µg mL−1 for ACF, and were validated following the ICH guidelines. The accuracy of laboratory-prepared mixtures ranged from 97–102%, with an intra-day precision relative standard deviation (R.S.D.) of less than 1% and an inter-day precision R.S.D. of less than 1.95%. Additionally, the root mean square error of prediction (RMSEP) was ≤1.0. The accuracy of co-formulated tablets was also satisfactory, with mean percentage recoveries falling within the range of 97-104.5%. Conclusion: The six suggested methods were simple, accurate, selective, quick, and eco-friendly, making them appropriate for routine analysis of the cited drugs in ternary mixtures and co-formulated tablets in quality-control laboratories.

Recommended Citation

Mozayad, Ayoub N.; Fouad, Marwa A.; and Elkady, Ehab F. (2024) "Design and validation of eco-friendly chemometric-assisted spectrophotometric methods for the simultaneous determination of chlorzoxazone, paracetamol, and aceclofenac in the presence of their main impurities," Bulletin of Faculty of Pharmacy Cairo University: Vol. 62 : Iss. 1 , Article 5.
Available at: https://doi.org/10.54634/2090-9101.1053