Abstract

STABILITY INDICATING RP-HPLC METHOD DEVLOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF EPLERENONE AND TORSEMIDE IN TABLET DOSAGE FORM.

Rinku B. Patel*, Bhumi R. Patel, Jaymin G. Patel and Viral S. Patel

ABSTRACT

A simple, rapid, economical, precise and accurate Stability indicating RP-HPLC method for simultaneous estimation of Eplerenone and Torsemide In Their Combined Dosage Form has been developed. A reverse phase high performance liquid chromatographic method was developed for the simultaneous estimation of Eplerenone and Torsemide. In Their Combined Dosage Form has been developed. The separation was achieved by LC- 20 AT C18 (250mm x 4.6 mm x 2.6 μm) column and Buffer (pH 3.5): Methanol (60:40) as mobile phase, at a flow rate of 1 ml/min. Detection was carried out at 276 nm. Retention time of Eplerenone and Torsemide were found to be 3.200 min and 5.023 min, respectively. The method has been validated for linearity, accuracy and precision. Linearity observed for Eplerenone 6.25-18.75 μg/ml and for Torsemide 2.5-7.5 μg/ml. Developed method was found to be accurate, precise and rapid for simultaneous estimation of Eplerenone and Torsemide In Their Combined Dosage Form. The drug was subjected to stress condition of hydrolysis, oxidation, photolysis and Thermal degradation, Considerable Degradation was found in alkaline degradation. The proposed method was successfully applied for the simultaneous estimation of both the drugs in commercial Combined dosage form.

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