LC–MS/TOF, LC–MSn and H/D Exchange Studies on Solifenacin Succinate Targeted to Characterize its Forced Degradation Products

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• 作者：Dilip Kumar Singh ; Moolchand Kurmi ; Tarun Handa ; Saranjit Singh
• 关键词：LC–MS/TOF ; MSn ; Solifenacin succinate ; Stress studies ; Degradation products
• 刊名：Chromatographia
• 出版年：2016
• 出版时间：February 2016
• 年：2016
• 卷：79
• 期：3-4
• 页码：159-168
• 全文大小：566 KB
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• 作者单位：Dilip Kumar Singh (1)
  Moolchand Kurmi (1)
  Tarun Handa (2)
  Saranjit Singh (1)
  
  1. Department of Pharmaceutical Analysis, National Institute of Pharmaceutical Education and Research (NIPER), Sector 67, S.A.S. Nagar, Punjab, 160 062, India
  2. Biocon-BMS R&D Centre (BBRC), Biocon Park, Bangalore, India
  
• 刊物类别：Chemistry and Materials Science
• 刊物主题：Chemistry
  Analytical Chemistry
  Organic Chemistry
  Pharmacy
  Biochemistry
  Plant Sciences
  Measurement Science and Instrumentation
  
• 出版者：Vieweg Verlag
• ISSN：1612-1112

文摘

Solifenacin was subjected to hydrolysis (acidic, basic and neutral), photolysis, oxidation and dry heat stress conditions, as prescribed by International Conference on Harmonisation guideline Q1A (R2). The drug was found to be unstable under oxidative and photolytic stress, but was stable to hydrolysis and thermal degradation. In total, three degradation products were formed, which were resolved from the drug and each other on a C-18 column employing a gradient elution method. A complete mass fragmentation pattern of the drug was established with the help of mass spectrometry/time of flight and multi-stage tandem mass spectrometric data. The structures of degradation products were elucidated through comparison of their mass fragmentation patterns with the drug. A most plausible mechanistic explanation for drug degradation is proposed. Keywords LC–MS/TOF MSn Solifenacin succinate Stress studies Degradation products