A Novel RP-HPLC Method for Determination of Esomeprazole in Pharmaceutical Dosage Forms in Human Plasma: A Pilot Stress Degradation Study

Esomeprazole, an proton pump inhibitor used for the remedy of acid reflux disorders including healing and maintenance of erosive esophagitis, gastroesophageal reflux disease and peptic ulcer disease. It is utilized in a prolonged treatment of pathological hypersecretory conditions such as Zollinger -Ellison syndrome. In this study, a novel RP-HPLC method was developed for the determination of esomeprazole both in API and tablets (Esmoz (40mg)), Phenomenex Luna, 5μm C18 100 A° LC column (250X4.6mm) was used at 40°C. Isocratic elution was utilized with acetonitrile: water (96:4v/v) mixture. The flow rate was 1.0mL min-1 and UV detection was at 270nm. The RT value was observed at 3.713 minutes respectively. The developed method was validated according to ICH guidelines and found to be linear within the range of 100-500μg/mL. In similar lines, linearity was achieved by spiking esomeprazole in human plasma within the range of 20-80μg/mL. The developed method was accurate, precise, robust, and rapid. Hence it can be applied for both stability studies and routine quality control analyses.