Acta Pharm. 68 (2018) 61-73

 

full paper

Original research paper

Advanced spectrophotometric chemometric methods for resolving the binary mixture of doxylamine succinate and pyridoxine hydrochloride

PLAMEN KATSAROV, GEORGI GERGOV, AYLIN ALIN, BISSERA PILICHEVA, YAHYA AL-DEGS, VASIL SIMEONOV and MARGARITA KASSAROVA

plamen.katsarov@yahoo.com

1 Department of Pharmaceutical Sciences, Faculty of Pharmacy, Medical University-Plovdiv,
4002 Plovdiv, Bulgaria

2 Department of Chemistry, Faculty of Pharmacy, Medical University Sofia, 1000 Sofia, Bulgaria

3 Department of Statistics, Dokuz Eylul University, 35160 Izmir, Turkey

4 Chemistry Department, The Hashemite University, P. O. Box 150459 Zarqa 13115, Jordan

5 Laboratory of Chemometrics and Environmetrics, Faculty of Chemistry and Pharmacy, Sofia University

“St. Kliment Ohridski”, 1164 Sofia, Bulgaria

6 High-technological Center of Emergency Medicine, Plovdiv, Bulgaria

Accepted November 15, 2017

Published online December 8, 2017

 

The prediction power of partial least squares (PLS) and multivariate curve resolution-alternating least squares (MCR-ALS) methods have been studied for simultaneous quantitative analysis of the binary drug combination – doxylamine succinate and pyridoxine hydrochloride. Analysis of first-order UV overlapped spectra was performed using different PLS models – classical PLS1 and PLS2 as well as partial robust M-regression (PRM). These linear models were compared to MCR-ALS with equality and correlation constraints (MCR-ALS-CC). All techniques operated within the full spectral region and extracted maximum information for the drugs analysed. The developed chemometric methods were validated on external sample sets and were applied to the analyses of pharmaceutical formulations. The obtained statistical parameters were satisfactory for calibration and validation sets. All developed methods can be successfully applied for simultaneous spectrophotometric determination of doxylamine and pyridoxine both in laboratory-prepared mixtures and commercial dosage forms.

 

Keywords: doxylamine succinate, pyridoxine hydrochloride, binary mixture, partial least squares (PLS), partial robust M-regression (PRM), multivariate curve resolution-alternative least squares (MCR-ALS)