Advanced stability indicating chemometric methods for quantitation of amlodipine and atorvastatin in their quinary mixture with acidic degradation products

Hany W Darwish; Said A Hassan; Maissa Y Salem; Badr A El-Zeany

doi:10.1016/j.saa.2015.10.007

Advanced stability indicating chemometric methods for quantitation of amlodipine and atorvastatin in their quinary mixture with acidic degradation products

Spectrochim Acta A Mol Biomol Spectrosc. 2016 Feb 5:154:58-66. doi: 10.1016/j.saa.2015.10.007. Epub 2015 Oct 8.

Authors

Hany W Darwish¹, Said A Hassan², Maissa Y Salem³, Badr A El-Zeany³

Affiliations

¹ Department of Analytical Chemistry, Faculty of Pharmacy, Cairo University, Kasr El-Aini Street, 11562 Cairo, Egypt; Department of Pharmaceutical Chemistry, College of Pharmacy, King Saud University, P.O. Box 2457, Riyadh 11451, Saudi Arabia.
² Department of Analytical Chemistry, Faculty of Pharmacy, Cairo University, Kasr El-Aini Street, 11562 Cairo, Egypt. Electronic address: said.hassan@pharma.cu.edu.eg.
³ Department of Analytical Chemistry, Faculty of Pharmacy, Cairo University, Kasr El-Aini Street, 11562 Cairo, Egypt.

PMID: 26513228
DOI: 10.1016/j.saa.2015.10.007

Abstract

Two advanced, accurate and precise chemometric methods are developed for the simultaneous determination of amlodipine besylate (AML) and atorvastatin calcium (ATV) in the presence of their acidic degradation products in tablet dosage forms. The first method was Partial Least Squares (PLS-1) and the second was Artificial Neural Networks (ANN). PLS was compared to ANN models with and without variable selection procedure (genetic algorithm (GA)). For proper analysis, a 5-factor 5-level experimental design was established resulting in 25 mixtures containing different ratios of the interfering species. Fifteen mixtures were used as calibration set and the other ten mixtures were used as validation set to validate the prediction ability of the suggested models. The proposed methods were successfully applied to the analysis of pharmaceutical tablets containing AML and ATV. The methods indicated the ability of the mentioned models to solve the highly overlapped spectra of the quinary mixture, yet using inexpensive and easy to handle instruments like the UV-VIS spectrophotometer.

Keywords: Amlodipine; Artificial neural networks; Atorvastatin; Genetic algorithm; Partial Least Squares; Stability indicating.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Amlodipine / analysis*
Antihypertensive Agents / analysis*
Atorvastatin / analysis*
Drug Combinations
Drug Stability
Hydroxymethylglutaryl-CoA Reductase Inhibitors / analysis*
Least-Squares Analysis
Neural Networks, Computer
Spectrophotometry / methods
Tablets

Substances

Antihypertensive Agents
Drug Combinations
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Tablets
Amlodipine
Atorvastatin