Structure Identification and Risk Assurance of Unknown Impurities in Pramipexole Oral Drug Formulation.

ABSTRACT: Impurities compounds in any pharmaceutical product or drug substance are inevitable from a chemistry point of view. The quality and safety of a pharmaceutical product are also significantly affected by these impurities content; therefore, impurities need to be identified and characterized through the use of appropriate analytical methods. Pramipexole is a nonergot dopamine agonist used to treat various Parkinson's disease symptoms. Two unknown impurities were detected from a pramipexole dihydrochloride solid dosage form. These impurities were identified and characterized using ultra-performance liquid chromatography coupled with high-resolution mass spectroscopy (UPLC-HRMS). These impurities were found to be enriched when mannitol existed in the formulation. The structure and mechanism inv

SUBMITTER: Tjandrawinata RR 

PROVIDER: S-EPMC10878758 | biostudies-literature | 2024

REPOSITORIES: biostudies-literature