A RAPID RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE QUANTITATIVE ESTIMATION OF EPLERENONE IN TABLETS
Keywords:
Nil, Eplerenone, Method development, ValidationAbstract
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 98â€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.
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References
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