A RAPID RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE QUANTITATIVE ESTIMATION OF EPLERENONE IN TABLETS


D. Vijay Kumar, S. Srinivas, A. Ashok Kumar

Abstract


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; 5μ), 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 15-45μg/ml. The precision is exemplified by relative standard deviation of 0.34%. Percentage Mean recovery was found to be in the range of 98‐102, during accuracy studies. The limit of detection (LOD) and limit of quantitiation (LOQ) was found to be 39.16μg/ml and 118.66μg/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.

 


Keywords


RP‐HPLC, Eplerenone, Method development, Validation

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References


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About this article

Title

A RAPID RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE QUANTITATIVE ESTIMATION OF EPLERENONE IN TABLETS

Keywords

RP‐HPLC, Eplerenone, Method development, Validation

Date

05-10-2015

Additional Links

Manuscript Submission

Journal

International Journal of Pharmacy and Pharmaceutical Sciences
Vol 7, Issue 11, 2015 Page: 360-364

Online ISSN

0975-1491

Statistics

217 Views | 131 Downloads

Authors & Affiliations

D. Vijay Kumar
Vijaya College of Pharmacy
India

S. Srinivas
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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