Synthesis, Isolation, Identification and Characterization of a Drug-Excipient Interaction Degradation Impurity in Pramipexole by HPLC, LC/MS and NMR

• Published in: Separations Vol. 10; no. 1; p. 7
• Main Authors: Al-Rifai, Nafisah, Alshishani, Anas, Saad, Bahruddin, Rasras, Anas, Zahra, Jalal, Madieh, Shadi, Darras, Fouad
• Format: Journal Article
• Language: English
• Published: Basel MDPI AG 01.01.2023
• Subjects: Acids; characterization; Chromatography; Degradation; Diamines; Dopamine; drug; Excipients; identification; Impurities; Ions; isolation; Mass spectrometry; Methods; NMR; Nuclear magnetic resonance; Parkinson's disease; Pharmaceuticals; pramipexole; Restless legs syndrome; synthesis; United States > US; Germany

A drug-excipient interaction impurity associated with the degradation process of pramipexole was isolated. The impurity was detected during the stability study of pramipexole extended-release tablets. It was found at a relative retention time of 0.88 with respect to pramipexole, using the pramipexol...