Abstract

DEVELOPMENT OF CHROMATOGRAPHIC METHOD FOR THE ESTIMATION OF EPLERENONE AND TORSEMIDE FROM THEIR DOSAGE FORMS

Monali R. Dakhole, Milind J. Umekar and Radheshyam T. Lohiya*

ABSTRACT

A simple, precise, accurate and reliable reverse-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the simultaneous estimation of Eplerenone (EPL) and Torsemide (TSM) in their combined tablet dosage form. The analysis was performed using a Shimadzu HPLC 1100 system with an ACE HPLC 5µ C18 (150 × 4.6 mm, 5µ) column. A phosphate buffer and acetonitrile mixture (50:50 v/v) was used as the mobile phase at a flow rate of 1.0 mL/min. Detection was carried out using a UV-Visible detector at 258 nm, with the column temperature maintained between 25–30°C. The retention times for EPL and TSM were 2.3 minutes and 3.7 minutes, respectively. The method demonstrated linearity within the concentration ranges of 10–50 µg/mL for EPL and 4–20 µg/mL for TSM, with a correlation coefficient (r²) of 0.999. The developed RP-HPLC method was validated as per ICH guidelines and is suitable for routine quality control analysis of Eplerenone and Torsemide in tablet formulations.

Keywords: Eplerenone, Torsemide, RP-HPLC Method, Validation.