A Quantification method for the determination of eplerenone polymorphs Form-H in Form-L was developed and validated by Diffuse Reflectance Infrared Fourier Transform spectroscopy (DRIFTS) using Beer’s law method. A series of standard spiked concentrations (2, 10, 22, 29, 48 and 100% w/w) were prepared by accurately weighing and mixing the pure polymorphs. Specimens were prepared in potassium bromide powder at the concentration of 2% w/w and the spectra were collected. A linear relationship between the content of Form-H and the peak area at about 1406 cm-1, corresponding to Form-H was observed with an excellent correlation coefficient 0.9996 and standard error of prediction is 2.2279 using Beer’s law method. The proposed method was found to be fast and reliable for the prediction of polymorphic content of eplerenone Form-H in Form-L in drug substance during processing and storage.
Eplerenone, Quantification, Diffuse reflectance infrared Fourier transform spectroscopy, Beer’s law method