TY  - JOUR
A1  - Leistner, Adrian
A1  - Holzgrabe, Ulrike
T1  - Impurity Profiling of Baclofen Using Gradient HPLC–UV Method
JF  - Chromatographia
N2  - The GABA\(_{B}\) receptor agonist baclofen is a medication commonly used for the treatment of muscle spasticity. It is an amino acid and related to the neurotransmitter GABA. In this study, we developed a new, gradient high-performance liquid chromatography (HPLC) method for the impurity assessment of baclofen, which is appropriate for pharmacopoeial purposes. Since the impurities related to the synthesis pathway are acids, zwitterionic, or neutral, the method development is challenging. However, the separation of all components was achieved on a C18 stationary phase using a water–acetonitrile–trifluoroacetic acid gradient. A limit of detection (LOD) of at least 0.02% was registered for all specified impurities. Additionally, CAD detection was performed to detect potential impurities lacking off a chromophore. The baclofen batches analyzed are far more pure than expected. All impurities were found below the specification limit, and thus, they can be regarded as unspecified. Moreover, the required runtime could be significantly reduced compared to the current USP or Ph. Eur. method.
KW  - GABA\(_{B}\)
KW  - impurity profiling
KW  - baclofen
KW  - gradient HPLC–UV
KW  - CAD detection
KW  - pharmaceutical analysis
Y1  - 2021
U6  - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:20-opus-268921
SN  - 1612-1112
VL  - 84
IS  - 10
ER  -