Method Development and Validation of RP-HPLC Method For Estimation of Eplerenone In Bulk and Pharmaceutical Formulations

Abstract

Objective:This method focused on development of simple, selective and precise liquid chromatographic method for determination of Eplerenone in API (Active Pharmaceutical Ingredient) and pharmaceutical formulations

Methods:This chromatographic method employed a C18 column with Isocratic mobile phase consisting of Acetonitrile and Phosphoric acid 0.1% (50:50, v/v). The UV detection was performed at 241 nm. This was followed with validation of developed procedure for as per ICH guidelines.

Results: The validation parameters of linearity, accuracy, precision, and specificity were found to be distinctable. There was no interference detected with neither excipients nor degradation products in the determination of active pharmaceutical ingredient and tablet formulation. The results presented a linear response over a range from 2 to 20 µg/ml with good accuracy and intra- and inter-day precision. The recovered values from pharmaceutical dosage form ranged from 98 to 102%.Moreover, Stability of the procedure was evaluated by subjecting solutions of Eplerenone and its drug products to four different stress conditions: acidic, oxidative, reductive and ultraviolet degradation. Moreover, forced degradation study was also performed under thermal stress and photolytic conditions.

Conclusions: Overall, the method developed was found to be suitable for routine quantitative determination of the active in both bulk and pharmaceutical tablet dosage form.