Title:Qualitative and Quantitative Chemometry as Stability-Indicating Methods for Determination of Dantrolene Sodium and Paracetamol
VOLUME: 14 ISSUE: 1
Author(s):Ali M. Yehia*, Iman Sami*, Safa'a M. Riad and Yasser S. El-Saharty
Affiliation:Cairo University, Faculty of Pharmacy, Department of Analytical Chemistry, Kasr El-Aini Street, ET 11562, Cairo, Cairo University, Faculty of Pharmacy, Department of Analytical Chemistry, Kasr El-Aini Street, ET 11562, Cairo, Cairo University, Faculty of Pharmacy, Department of Analytical Chemistry, Kasr El-Aini Street, ET 11562, Cairo, Cairo University, Faculty of Pharmacy, Department of Analytical Chemistry, Kasr El-Aini Street, ET 11562, Cairo
Keywords:Dantrolene sodium, paracetamol, stability indicating methods, PLS, CRACLS, MCR-ALS.
Abstract:Background: Simultaneous determination of binary mixtures with simple and cost effective
analysis is always of interest. Progressive advancement in chemometrics enables spectral resolution of
drugs in the presence of their degradation products or impurities.
Methods and Result: Three stability indicating chemometric methods are applied for the simultaneous
determination of Dantrolene sodium (DNT) and Paracetamol (PAR). Partial Least Squares (PLS), Concentration
Residuals Augmented Classical Least Squares (CRACLS) and Multivariate Curve Resolution-
Alternating Least Squares (MCR-ALS) were selected for that purpose. DNT and PAR were determined
in the linearity range of (2 – 10 µg mL-1) and (12 – 28 µg mL-1), respectively, in the presence of
their degradation products. The presented methods were compared for their qualitative and quantitative
analyses and validated according to the ICH guidelines. Furthermore, statistical comparison between the
results obtained by the proposed methods and the reported chromatographic method showed no significant
differences.
Conclusion: The proposed multivariate calibrations were accurate and specific for quantitative analysis
of the studied components. Furthermore, CRACLS and MCR-ALS methods succeeded in both quantitative
and qualitative of the studied components and their degradation products.
