A RAPID RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE QUANTITATIVE ESTIMATION OF EPLERENONE IN TABLETS
Keywords:Nil, Eplerenone, Method development, Validation
Objective: To develop a rapid, sensitive, accurate, precise, linear and rugged Reverse Phase High Performance Liquid Chromatographic (RP-HPLC) method and validate as per ICH guidelines for the quantitative estimation of Eplerenone in tablets.
Methods: The optimized method uses a reverse phase column, Waters Symmetry C18 (250 X 4.6 mm; 5Î¼), a mobile phase of triethylammonium phosphate buffer (pH 2.3):acetonitrile in the proportion of 40:60 v/v, flow rate of 1.0 ml/min and a detection wavelength of 240 nm using a UV detector.
Results: The developed method resulted in Eplerenone eluting at 3.63 min. Eplerenone exhibited linearity in the range 15-45Î¼g/ml. The precision is exemplified by relative standard deviation of 0.34%. Percentage Mean recovery was found to be in the range of 98â€102, during accuracy studies. The limit of detection (LOD) and limit of quantitiation (LOQ) was found to be 39.16Î¼g/ml and 118.66Î¼g/ml respectively.
Conclusion: A sensitive, rapid, accurate, precise, linear and rugged RP-HPLC method was developed and validated for the quantitative estimation of Eplerenone in tablets as per ICH guidelines and hence it can be used for routine analysis in various pharmaceutical industries.
Brajesh M, Naina K, Shashank S. Quantitative determination of eplerenone in bulk drug and tablet dosage form by TLC/densitometry. Int J Pharm Life Sci 2011;2;502-5.
Charles T, Stier Jr. Eplerenone: a selective aldosterone blocker. Cardiovasc Drug Rev 2003;21:169-84.
Naresh Chandra Reddy M, Chandra sekhar KB. Development and validation of gradient RP-HPLC for estimation of impurities in Eplerenone tablet dosage form. Int Res J Pharm App Sci 2012;2:58-75.
Weinberger MH, Roniker B, Krause SL, Weiss RJ. Eplerenone, a selective Aldosterone blocker, in mild-to-moderate hypertension. Am J Hypertens 2002;15:709-16.
White WB, Duprez D, St Hillaire R, Krause S, Roniker B, Kuse-Hamilton J, et al. Effects of the selective aldosterone blocker Eplerenone versus the calcium antagonist Amlodipine in systolic hypertension. Hypertension 2003;41:1021-6.
Moore TD, Nawarskas JJ, Anderson JR. Eplerenone: a selective aldosterone receptor antagonist for hypertension and heart failure. Heart Dis 2003;5:354-63.
Chatterjee S, Moeller C, Shah N, Bolorunduro O, Lichstein E, Moskovits N, et al. Eplerenone is not superior to older and less expensive aldosterone antagonists. Am J Med 2011;125:817-25.
Zhang JY, Fast DM, Breau AP. Development and validation of a liquid chromatography-tandem mass spectrometric assay for Eplerenone and its hydrolyzed metabolite in human plasma. J Chromatogr B: Anal Technol Biomed Life Sci 2003;25;787:333-44.
Zhang JiY, Douglas MF, Breau AP. A validated SPEâ€“LC-MS/MS assay for Eplerenone and its hydrolyzed metabolite in human urine. J Pharm Biomed Anal 2003;31:103-15.
Naina K, Brajesh M, Shashank S. Development and validation of UV-Spectrophotometric determination of eplerenone in bulk and tablets. Int J Pharm Life Sci 2010;1:231-3.
Banode VS, Khedekar PB, Tarte PS. Spectrophotometric estimation of Eplerenone in bulk drug and tablets. Int J Chem Tech Res 2011;3:398-402.
Rane K, Patil R, Sangshetti JN, Yeole RD, Shinde DB. Stability-indicating RP-HPLC method for analysis of Eplerenone in the bulk drug and in a pharmaceutical dosage form. Acta Chromatogr 2009;21:619-9.
International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human use. Validation of Analytical Procedures: Text and Methodology ICH Q2 (R1); 2005.