TY  - JOUR
AV  - none
IS  - 1
N2  - 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 pramipexole gradient HPLC-UV detection method described in the USP. The structure of the impurity was identified and fully characterized using high resolution mass spectrometry, IR and NMR techniques, as presented herein. The degradation impurity was identified as (S)-N2-(methoxymethyl)-N6-propyl-4,5,6,7-tetrahydro-1,3-benzothiazole-2,6-diamine. The drug-excipient interaction mechanism of its formation was proposed. An efficient and straightforward synthetic approach was developed to prepare the degradation impurity to confirm its proposed degradation pathway and structure. © 2022 by the authors.
N1  - cited By 2
ID  - scholars19386
TI  - Synthesis, Isolation, Identification and Characterization of a Drug-Excipient Interaction Degradation Impurity in Pramipexole by HPLC, LC/MS and NMR
Y1  - 2023///
A1  - Al-Rifai, N.
A1  - Alshishani, A.
A1  - Saad, B.
A1  - Rasras, A.
A1  - Zahra, J.
A1  - Madieh, S.
A1  - Darras, F.
JF  - Separations
UR  - https://www.scopus.com/inward/record.uri?eid=2-s2.0-85146763954&doi=10.3390%2fseparations10010007&partnerID=40&md5=4c68c7807a2c5a7a08f2e0776a7a8d8c
VL  - 10
ER  -