New stability-indicating ultra-fast liquid chromatographic method for the determination of eplerenone - An antimineralocorticoid

Abstract

Introduction: A new stability indicating RP-UFLC method has been developed for the assay of Eplerenone in presence of and internal standard. Eplerenone is used for the treatment of hypertension, central serious retinopathy and especially in the treatment cardio vascular diseases. Materials and Methods: Shimadzu HPLC system (PDA detector) using Agilent column (150 mm × 4.6 mm i.d., 3.5 µm particle size) and (isocratic mode) was used for the chromatographic study of Eplerenone with the mixture of 10 mM tetra butyl ammonium hydrogen sulphate and acetonitrile (50:50, v/v) (UV detection at 242 nm) with flow rate 0.8 mL/min. Stress degradation studies were performed by treating Eplerenone with different reagents to study the degradation profile and the proposed method was validated as per ICH guidelines. Results and Discussion: Beer-Lambert’s law was obeyed 0.1-40 µg/mL (Correlation coefficient 0.9998). The LOD and LOQ are found to be 0.0291 µg/mL and 0.0863 µg/mL respectively. Conclusions: The proposed RP-UFLC method is precise, accurate and sensitive and the method can be used for the routine analysis of Eplerenone pharmaceutical formulations (Tablets).