STABILITY-INDICATING HPTLC METHOD FOR DETERMINATION OF EPLERENONE
Dr. Mrinalini C. Damle* and Snehal M. Dumbre
ABSTRACT
A simple and economical thin-layer chromatography /densitometry method has been developed for determination of eplerenone. The method was validated as per International Conference on Harmonization (ICH) guidelines. Aluminium TLC plates precoated with silica gel 60F254 were used as the stationary phase and ethyl acetate: toluene 7:3 (v/v) as mobile phase. A compact band (Rf 0.52 ± 0.03) was obtained for Eplerenone. Densitometric analysis was performed in the absorbance mode at 238 nm. Linear regression analysis revealed a good linear relationship with (R2 = 0.990 ± 0.0004) between peak area and concentration in the range 1500 - 9000 ng/band. The mean value of the slope and intercept were 2.29 and 7126.9 respectively.The limits of detection and quantitation were 114.06 ng/band and 345.64 ng/band, respectively. Eplerenone was subjected to acid , alkali hydrolysis, oxidation, photochemical and thermal degradation.
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