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THE PHARMA REVIEW (JUNE 2008)

RP-HPLC Estimation of Eplerenone in Tablets

K. P. Bhusari, P. B. Khedekar, N. D. Amnerkar, S. M. Dhole, V. S. Banode

Abstract: A method for the determination of Eplerenone in tablets has been developed using reverse phase high performance liquid chromatographic method. The elution was done using a mobile phase consisting of methanol and water (75 : 25 v/v) on RP-C18 250 x4.6 mm analytical column with flow rate of 1 ml/min with detection at 243 nm. The elution time was 4.02 min. The method was found suitable for quantitative estimation of eplerenone in tablets.

Introduction
Eplerenone (EPL) is chemically 9a,11a-Epoxy-7a-methylcarboxy-3-oxo-17a-pregn-4-en-21,17b carbolactone, which is used as selective aldosterone bloker, antihypertensive and diuretic.1,2 Eplerenone binds to the mineralocorticoid receptor and blocks the binding of aldosterone, a component of renin-angiotensin-aldosterone system.3,4 It is listed in Martindale.5 Literature survey revealed SPE LC-MS/MS assay for eplerenone and its hydrolysed metabolite in human urine.6 The present work describes the simple, isocratic RP-HPLC method for the determination of EPL in tablets. The developed method was validated using ICH guidelines for validation.7

Materials and Method
The drug sample, Eplerenone, was obtained as gift sample from MSN Lab. Pvt. Ltd., Medak. HPLC grade methanol and water were supplied by Merck Co, Mumbai.

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