Green Assessment-Based Stability-Indicating Rp-Hplc Method Development And Validation For The Determination Of Vonoprazan Fumarate In Bulk And Formulations
Year: 2024
Type: article
Abstract: A rapid and reliable Green Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) method was developed and validated for the estimation of Vonoprazan Fumarate in pharmaceutical formulations. The method utilized a BDS Hypersil C18 column (250 × 4.6 mm, 5 µm) with a mobile phase of water (pH 3.0) and acetonitrile (95:5, v/v) under isocratic conditions. Detection was performed at 213 nm using a PDA detector, with a flow rate of 0.8 mL/min and a retention time of 3.9 minutes. Linearity was established in the 10–60 µg/mL range, with a recovery of 98.90%. The method demonstrated stability-indicating properties through forced degradation studies. Greenness was assessed using AGREE (0.86), AGREEprep (0.77), and BAGI (75), confirming its environmental and industrial feasibility. The developed RP-HPLC method, validated according to ICH guidelines, is suitable for analyzing Vonoprazan Fumarate in pharmaceutical formulations. Forced degradation studies confirmed its stability-indicating capability. This study highlights the method’s balance between efficiency and environmental responsibility.
Author: Gauri N. Rajage
Language: English
Subfield: Analytical Chemistry
Field: Chemistry
Domain: Physical Sciences
Open Access status: diamond
OpenAlex ID: W4409276980