A RAPID ASSAY METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF EPLERENONE IN TABLETS BY UV SPECTROPHOTOMETRY


B. Shailaja, K. Swarna, M. Afreen, A. Ashok Kumar

Abstract


Objective: To develop a rapid, simple and a cheap UV spectrophotometric assay method for the estimation of Eplerenone in tablets and validate as per ICH guidelines.

Methods: The optimized method uses 0.05N HCl as a solvent for the estimation of assay of Eplerenone in tablets at a detection wavelength of 245 nm.

Results: System precision and intra-day precision are exemplified by relative standard deviation of 1.5% and 1.3% respectively. Method was found to be rugged as precision was found to be 1.2%. The developed method resulted in Eplerenone exhibiting linearity in the range 5-15μg/ml. Percentage Mean recovery was found to be in the range of 98‐102, during accuracy studies.

Conclusion: A rapid, simple and a cheap UV spectrophotometric assay method was developed and validated for the estimation of Eplerenone in tablets as per ICH guidelines and hence it can be used for the routine analysis in various pharmaceutical industries.

 


Keywords


UV, Eplerenone, Method development, Validation

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References


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 Appl 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;787:333-44.

Zhang JiY, Douglas MF, Breau AP. A validated SPE–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;21:619-29.

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.




About this article

Title

A RAPID ASSAY METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF EPLERENONE IN TABLETS BY UV SPECTROPHOTOMETRY

Keywords

UV, Eplerenone, Method development, Validation

Date

22-07-2015

Additional Links

Manuscript Submission

Journal

International Journal of Pharmacy and Pharmaceutical Sciences
Vol 7, Issue 9, 2015 Page: 327-330

Online ISSN

0975-1491

Statistics

187 Views | 172 Downloads

Authors & Affiliations

B. Shailaja
Vijaya college of pharmacy
India

K. Swarna
Vijaya college of pharmacy
India

M. Afreen
Vijaya college of pharmacy
India

A. Ashok Kumar
Department of Pharmaceutical analysis and Quality Assurance, Vijaya college of pharmacy, Munaganur (village), Hayathnagar (mandal), Hyderabad 501511, India
India


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