Qualitative and quantitative chemometry as stability-indicating methods for determination of dantrolene sodium and paracetamol

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.