Review Of RP-HPLC-Based Analytical Methods For The Determination Of Vericiguat In Bulk And Dosage Forms
DOI:
https://doi.org/10.46647/rdems0207009Keywords:
ICH guidelines, method development, RP-HPLC, Validation and Vericiguat.Abstract
Vericiguat drug substance is used to cure chronic heart diseases. For safely use of Vericiguat drug in daily life with appropriate control of its potential impurities and its accurate intake of below reporting level is important and crucial role to decide quality of drug molecule, cost effective analysis technique and meeting with regulatory norms. High-Performance Liquid Chromatography (HPLC) technique is broadly working to check exact content of drug molecule in bulk drug or formulated dosage form, outstanding for its lowest level detection, specific and flexibility of analysis. This review provides a detailed overview of RP-HPLC procedures established for the identification and check content of Vericiguat, highlighting method development parameters such as stationary phase selection, mobile phase composition, detection wavelength, and validation parameters. Recent advancements including stability-indicating methods and green analytical approaches are discussed. This review also emphasizes regulatory requirements, particularly ICH guidelines, and identifies gaps in the current literature that helps to future research.