Item request has been placed! ×
Item request cannot be made. ×
loading  Processing Request

Characterization of process-related impurities including forced degradation products of alogliptin benzoate and the development of the corresponding reversed-phase high-performance liquid chromatography method.

Item request has been placed! ×
Item request cannot be made. ×
loading   Processing Request
اقرأ على الانترنت اقرأ أكثر حفظ في قائمتي
  • المؤلفون: Zhou Y;Zhou Y; Zhou W; Sun L; Zou Q; Wei P; OuYang P
  • المصدر:
    Journal of separation science [J Sep Sci] 2014 Jun; Vol. 37 (11), pp. 1248-55. Date of Electronic Publication: 2014 Apr 25.
  • نوع النشر :
    Evaluation Study; Journal Article
  • اللغة:
    English
  • معلومة اضافية
    • المصدر:
      Publisher: Wiley-VCH Country of Publication: Germany NLM ID: 101088554 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1615-9314 (Electronic) Linking ISSN: 16159306 NLM ISO Abbreviation: J Sep Sci Subsets: MEDLINE
    • بيانات النشر:
      Original Publication: Weinheim, Germany : Wiley-VCH, c2001-
    • الموضوع:
      Benzoates/*chemistry ; Chromatography, High Pressure Liquid/*methods ; Chromatography, Reverse-Phase/*methods ; Piperidines/*chemistry ; Uracil/*analogs & derivatives; Drug Stability ; Molecular Structure ; Uracil/chemistry
    • نبذة مختصرة :
      The characterization of process-related impurities and forced degradants of alogliptin benzoate (Alb) in bulk drugs and a stability-indicating HPLC method for the separation and quantification of all the impurities were investigated. Alb was found to be unstable under acid and alkali stress conditions and two major degradation products (Imp-F and Imp-G) were observed. The optimum separation was achieved on Kromasil C18 (250 × 4.6 mm, 5 μm) using 0.1% perchloric acid (pH adjusted to 3.0 with triethylamine) and acetonitrile as a mobile phase in gradient mode. The proposed method was found to be stability indicating, precise, linear (0.10-75.0 μg/mL), accurate, sensitive, and robust for the quantitation of Alb and its process-related substances and degradation products. The structures of 11 impurities were characterized and confirmed by NMR spectroscopy, MS, and IR spectroscopy, and the most probable formation mechanisms of all impurities were proposed according to the synthesis route.
      (© 2014 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.)
    • Contributed Indexing:
      Keywords: Alogliptin benzoate; Forced degradation; Process-related impurities; Quantification; Structural elucidation
    • الرقم المعرف:
      0 (Benzoates)
      0 (Piperidines)
      56HH86ZVCT (Uracil)
      JHC049LO86 (alogliptin)
    • الموضوع:
      Date Created: 20140312 Date Completed: 20150420 Latest Revision: 20191210
    • الموضوع:
      20250114
    • الرقم المعرف:
      10.1002/jssc.201301384
    • الرقم المعرف:
      24616424