Stability Indicating HPLC Method Development and Validation for The Estimation of Epoprostenol Sodium in Pharmaceutical Dosage Form

A robust and precise HPLC (Reverse Phase High-Performance Liquid Chromatography) method was developed and validated for the estimation of Epoprostenol Sodium in Injectable dosage forms. The chromatographic separation was achieved on a C18 column using a mobile phase comprising Acetonitrile: Ammonium Acetate Buffer (60:40v/v) in an optimized ratio under isocratic conditions. The flow rate was set to 1.0 mL/min with detection at 217 nm. The method demonstrated excellent linearity for both Epoprostenol Sodium over their respective concentration ranges with correlation coefficients exceeding 0.98. The precision, accuracy, and recovery results were within acceptable limits as per ICH guidelines. The method was also evaluated for specificity, robustness, and system suitability, confirming its reliability for routine quality control analysis of Epoprostenol Sodium in combined dosage forms.