Facile Access to Solifenacin Impurity K: One-Step Synthesis and an HPLC-MS Method for Its Determination.

Autor: Xifra R; Research and Development Center for Organic Chemistry, (CIDQO, S.L.), Polígono Industrial 'Can Verdalet', Calle D, Nave 91, 08490 Tordera, Spain., Lukach AE; Research and Development Center for Organic Chemistry, (CIDQO, S.L.), Polígono Industrial 'Can Verdalet', Calle D, Nave 91, 08490 Tordera, Spain., Turcu AL; Laboratory of Medicinal Chemistry (Associated Unit to CSIC), Faculty of Pharmacy and Food Sciences, University of Barcelona, Avinguda Joan XXIII, 27-31, 08028 Barcelona, Spain.; Institute of Biomedicine of the University of Barcelona (IBUB), University of Barcelona, 08028 Barcelona, Spain.
Jazyk: angličtina
Zdroj: Molecules (Basel, Switzerland) [Molecules] 2024 Jun 25; Vol. 29 (13). Date of Electronic Publication: 2024 Jun 25.
DOI: 10.3390/molecules29133011
Abstrakt: Solifenacin (SFC) is a potent muscarinic antagonist that effectively reduces bladder muscle contraction, thereby alleviating symptoms such as frequency of micturition and urgency. Oxidation of SFC leads to the formation of impurities like Impurity K. Effective analysis and control of this impurity is crucial for ensuring compliance with regulatory standards and safeguarding patient health. To address these challenges, we propose a novel one-step synthesis of Impurity K from SFC. Impurity K was synthesized using cerium(IV) ammonium nitrate (CAN) in water/acetonitrile as the solvent. Additionally, we describe a new HPLC-MS method for the detection of Impurity K in solifenacin succinate tablets.
Competing Interests: Authors Raúl Xifra and Andrés E. Lukach were employed by the company Research and Development Center for Organic Chemistry, (CIDQO, S.L.). The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
Databáze: MEDLINE