Chemometric-assisted spectrophotometric approach for stability assessment of safinamide and its synthetic precursor in antiparkinsonian formulation with sustainability profiling.

ABSTRACT: Parkinson's disease (PD) is a significant health issue that affects older individuals. Safinamide mesylate (SAF) is a recently developed adjunct therapy increasingly employed in the management of PD. Ensuring the stability of new drug formulations and establishing suitable stability-indicating methodologies is crucial for pharmaceutical analysis. The current study has developed three new, user-friendly, and robust mathematical methods using multivariate spectrophotometric analysis to quantify SAF, its synthetic precursor impurity (4-HBD), and stress-induced degradation products. The multivariate algorithms used include principal component regression (PCR), partial least squares (PLS), and synergy intervals partial least squares (siPLS). The ranges of the proposed methods were 3.00-23.00, 1

SUBMITTER: Ibrahim EA 

PROVIDER: S-EPMC12672687 | biostudies-literature | 2025 Nov

REPOSITORIES: biostudies-literature