## Impurity Profiling of Baclofen Using Gradient HPLC–UV Method

Please always quote using this URN: urn:nbn:de:bvb:20-opus-268921
• 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 onThe 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.

Author: Adrian Leistner, Ulrike Holzgrabe urn:nbn:de:bvb:20-opus-268921 Journal article Fakultät für Chemie und Pharmazie / Institut für Pharmazie und Lebensmittelchemie English Chromatographia 1612-1112 2021 84 10 927–935 Chromatographia 2021, 84(10):927–935. DOI: 10.1007/s10337-021-04079-y https://doi.org/10.1007/s10337-021-04079-y 5 Naturwissenschaften und Mathematik / 54 Chemie / 540 Chemie und zugeordnete Wissenschaften CAD detection; GABA$$_{B}$$; baclofen; gradient HPLC–UV; impurity profiling; pharmaceutical analysis 2022/06/10 CC BY: Creative-Commons-Lizenz: Namensnennung 4.0 International