A stability indicating method development and validation of apixaban in pharmaceutical dosage form by using RP-HPLC and In-Vitro evaluation of apixaban suspension delivery through enteral feeding tubes

Abstract

A simple, consistent and sensitive stability indicating reversed phase high performance liquid chromatography (RP-HPLC) method was developed for the determination of Apixaban in pharmaceutical dosage form by using Zorbax C18 (150 mm x 4.6 mm, 5μm particle size) with a mobile phase consisting of Ammonium Formate Buffer: Acetonitrile in a ratio of 65:35% v/v and successfully validated as per the international council for harmonization (ICH) guideline. The method was found to be simple, robust, precise, sensitive, accurate; specific and stress degradation studies were performed with acidic, alkaline, oxidative, thermal, humidity and photolytic stress conditions as per ICH guidelines. In separate in-vitro experiments, Apixaban suspension passed through feeding tubes to develop a clog-free suspension delivery method. Nasogastric tube (8-French [Fr]) and diluents (water, 5% dextrose in water) were tested. Recovery of Apixaban Suspension in water and 5% dextrose in water at “0 and 15” minutes incubation time were nearly 100% in 8-Fr nasogastric (NG) tubes. Keywords: Apixaban, Stress Degradation, Stability Indicating Assay Method, Nasogastric Tube.