An Extensive Comparison of Analytical Data Using Various Stability Condition of Non-Steroidal Anti-Inflammatory Drug (NSAID) For Paracetamol Infusion of Various Manufacturers of Branded (Innovator) Drug Product and Generic Drug Product

Abstract

This study aims to present comprehensive comparative analytical data on stability tests for non-steroidal anti-inflammatory drugs (NSAIDs), such as Paracetamol infusion. Pharmaceutical products from various manufacturers were bought from a medical supply store. Each of the medicinal products those were chosen were examined physically and maintained under various stability conditions. Intravenous paracetamol is an analgesic and antipyretic agent, recommended worldwide as a first-line agent for the treatment of pain and fever in adults and children. The drug products were kept for testing under two distinct stability conditions: 30°C(±5°C)/65%RH(±5%RH) and 40°C(±5°C)/75%RH(±5%RH). Samples were examined at various stability time intervals. Reverse Phase-High Performance Liquid Chromatography (RP-HPLC) was used to analyse the samples both qualitatively and quantitatively utilizing Indian Pharmacopeia (IP) techniques. According to Indian Pharmacopeia specifications, all drug product’s assay and associated impurities were confirmed to be within permissible limits based on the analytical data. The data analysis reveals that all manufacturer-produced medications are stable under both stability scenarios and are safe for patients to take regardless of cost.