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Abstract
Indomethacin oral suspension is a widely used non-steroidal anti-inflammatory drug (NSAID) formulation intended for patients requiring flexible dosing, rapid therapeutic onset, or difficulty swallowing solid dosage forms. The suspension provides enhanced dosing accuracy, especially in pediatric and geriatric populations, and ensures uniform distribution of the drug within the gastrointestinal tract. Indomethacin exerts its pharmacological effect primarily by inhibiting cyclooxygenase (COX-1 and COX-2) enzymes, leading to a reduction in prostaglandin synthesis that mediates inflammation, pain, and fever. Due to its high lipophilicity, the drug quickly achieves therapeutic plasma concentrations, offering effective relief in conditions such as rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, and acute gouty arthritis.The formulation contains ethanol as a co-solvent to improve solubility and maintain suspension stability. As ethanol is a volatile organic component, its accurate quantification is essential for product quality, patient safety, and regulatory compliance. Gas Chromatography (GC) with headspace analysis was employed for determining ethanol content in the formulation due to its sensitivity and selectivity. Method validation parameters, including system precision, linearity, method precision, intermediate precision, accuracy, specificity, and robustness, were thoroughly evaluated. The analytical method demonstrated excellent precision, linearity across the tested concentration range, accurate recovery of ethanol, and no interference from placebo or diluents at the retention times of ethanol and isopropyl alcohol. Robustness studies confirmed the reliability of the method under deliberate variations in analytical conditions. Overall, the validated GC method is suitable for routine quality control of ethanol in Indomethacin oral suspension.