Affiliation:
1. Department of Drugs and Pharmaceutics, Faculty of Pharmacy, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil
Abstract
Abstract
Background
Rotigotine is a dopaminergic agonist developed for the treatment of Parkinson’s disease and restless leg syndrome. The pure levorotatory enantiomer is marketed in several countries as a transdermal patch. Reports of oxidation and instability in a previous formulation indicate the need to evaluate impurities in both the raw material and pharmaceutical dosage forms of rotigotine to ensure product quality.
Objective
This review examines the main analytical methods for analyzing rotigotine in raw material and its transdermal patches with the aim of assisting the development of new pharmaceutical formulations and stability studies.
Methods
Analytical methods based on high-performance liquid chromatography for rotigotine from pharmacopoeias and literature were evaluated. A comparison was made between the methods found in the literature and official rotigotine monographs described by the United States, European, and British Pharmacopoeias, including a discussion of their acceptance limits for impurities related to the drug. The different impurities from the synthesis processes and degradation studies of rotigotine were also evaluated, as well as the main articles that describe methods for assessing their chiral purity.
Results
Qualified and unofficial official impurities found in forced degradation studies were verified. The methods presented show adequate specificity and selectivity in determining the drug in the presence of its impurities.
Conclusions
The approached methods are promising, but more detailed studies on the stability of rotigotine are still lacking, mainly in the pharmacokinetic and toxicological characterization of its impurities.
Funder
Conselho Nacional de Desenvolvimento Científico e Tecnológico - CNPq
Publisher
Oxford University Press (OUP)
Subject
Pharmacology,Agronomy and Crop Science,Environmental Chemistry,Food Science,Analytical Chemistry
Cited by
2 articles.
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