A Comprehensive Review of analytical approaches for quantification of the neuromodulating drug safinamide mesylate in different matrices | ||
| Journal of Pharmaceutical Sciences and Drug Manufacturing-Misr University for Science and Technology | ||
| Articles in Press, Accepted Manuscript, Available Online from 18 November 2025 | ||
| Document Type: Review Articles. | ||
| DOI: 10.21608/jpsdm.2025.429536.1040 | ||
| Authors | ||
| Engy Ashraf Ibrahim* 1; Samah S. Saad1; Maha A. Hegazy2; Laila E. Abdelfattah1; Hoda M. Marzouk3 | ||
| 1Pharmaceutical Analytical Chemistry Department, College of Pharmaceutical Sciences and Drug Manufacturing, Misr University for Science and Technology, 6th of October City 12566, Egypt. | ||
| 2Pharmaceutical Chemistry Department, Faculty of Pharmacy, Future University in Egypt, Cairo 11835, Egypt. | ||
| 3Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Cairo 11562, Egypt. | ||
| Abstract | ||
| Background: The continuous advancement of pharmaceutical formulations has created an increasing demand for innovative analytical methods capable of accurately quantifying active pharmaceutical ingredients in diverse quality control settings. Among antiparkinsonian agents, safinamide mesylate (SAF) has gained analytical importance due to its therapeutic role and the necessity for detailed stability and impurity profiling in both formulation and biological matrices. Objectives: This review aims to compile and critically assess the analytical methodologies developed for determining SAF in bulk drug substances, pharmaceutical dosage forms, and biological samples. The objective is to highlight techniques that provide an optimal combination of simplicity, sensitivity, reliability, and environmental sustainability. Methods: A comprehensive survey of the literature was conducted, covering various analytical techniques including chromatographic, spectrophotometric, electrochemical, and hyphenated methods. The review focuses on their applications in quantifying SAF alongside its synthetic precursor and stress-induced degradation products. Additionally, their suitability for routine quality control analysis and stability assessment. Results: The reported analytical methods demonstrated excellent performance in terms of precision, accuracy, and reproducibility for the determination of SAF under a wide range of analytical conditions. Many of these methods also proved effective for impurity and stability profiling, supporting their use in both research and industrial quality control environments. Conclusion: The reviewed literature emphasizes recent progress in analytical strategies for SAF determination. These advanced approaches balance analytical efficiency with environmental responsibility, making them appropriate for routine quality control, stability assessment, and impurity profiling in pharmaceutical analysis. | ||
| Keywords | ||
| Chromatography; Electrochemical methods; Safinamide Mesylate; Spectrophotometry; Stability indicating methods | ||
|
Statistics Article View: 1 |
||
