PDF(Pubmed)
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.
摘要：
索利那新（SFC）是一种有效的毒蕈碱拮抗剂，可有效减少膀胱肌肉收缩，从而减轻症状，如排尿频率和尿急。SFC的氧化导致杂质K的形成。这种杂质的有效分析和控制对于确保符合监管标准和保护患者健康至关重要。为了应对这些挑战，我们提出了一种由SFC一步法合成杂质K的新方法。使用硝酸铈(IV)铵(CAN)在水/乙腈作为溶剂中合成杂质K。此外,我们描述了一种新的HPLC-MS方法，用于检测琥珀酸索利那新片剂中的杂质K。
