A novel stability-indicating HPLC method for determining vorapaxar and conducting high-resolution mass spectroscopic characterization and molecular docking studies on its novel degradation product

LEVENT S., Elris A., ÖZCAN S., CAN N. Ö.

MICROCHEMICAL JOURNAL, cilt.210, 2025 (SCI-Expanded) identifier identifier

  • Yayın Türü: Makale / Tam Makale
  • Cilt numarası: 210
  • Basım Tarihi: 2025
  • Doi Numarası: 10.1016/j.microc.2025.113002
  • Dergi Adı: MICROCHEMICAL JOURNAL
  • Derginin Tarandığı İndeksler: Science Citation Index Expanded (SCI-EXPANDED), Scopus, Academic Search Premier, BIOSIS, CAB Abstracts, Chemical Abstracts Core, Chimica, Food Science & Technology Abstracts, Index Islamicus, Veterinary Science Database
  • Anadolu Üniversitesi Adresli: Evet

Özet

Vorapaxar is the only approved medicine that can prevent recurrent ischemic disease in people who have had previous peripheral artery disease or heart attacks by inhibiting the PAR-1 receptor. This research created a reliable HPLC method to accurately measure the amount of vorapaxar in pharmaceutical products, even when other substances might be present. For the chromatographic system, a Supelco Ascentis (R) Express C18 100 x 3.0 mm column was the stationary phase, and the system was worked with comprised of ammonium format: acetonitrile (55:45, v/v) in the mobile phase. In the recovery studies, the employed samples were the pseudo formulation of the in vitro-prepared Zontivity (R) tablet. Additionally, the degradation product investigated in the stability investigations was identified using a high-resolution mass spectrometry, which didn't have a Chemical Abstracts Services registry number, and to predict its potential formation pathway. The molecular docking simulation of vorapaxar and its degradant with the PAR-1 receptor was also studied.