Facile Access to Solifenacin Impurity K: One-Step Synthesis and an HPLC-MS Method for Its Determination-Reference-Cited by-同舟云学术

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

Published:2024-06-25 Issue:13 Volume:29 Page:3011
ISSN:1420-3049
Container-title:Molecules
language:en
Short-container-title:Molecules

Author:

Xifra Raúl¹,Lukach Andrés E.¹,Turcu Andreea L.²³^ORCID

Affiliation:

1. Research and Development Center for Organic Chemistry, (CIDQO, S.L.), Polígono Industrial “Can Verdalet”, Calle D, Nave 91, 08490 Tordera, Spain

2. 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

3. Institute of Biomedicine of the University of Barcelona (IBUB), University of Barcelona, 08028 Barcelona, Spain

Abstract

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.

Funder

Combino Pharm, S.L.

Publisher

MDPI AG

Link

https://www.mdpi.com/1420-3049/29/13/3011/pdf

Reference19 articles.

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