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

Abstract

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® Express C18 100 × 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® 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.