4.1 Introduction:
Eplerenone is marketed by Pfizer as inspra. It acts as aldosterone Opponent used to treat congestive heart failure.It acts as potassium-sparing diuretic also. It is used in the treatment of diabetic neuropathy in combination with enalapril (10).
It acts by rising the levels of aldosterone in the plasma.it has also high water retaining capacity.It deals with the sodium reabsorption and possibly other mechanisms (9).
The absolute bioavailability of the Eplerenone is unknown. It is metabolized primarily by CYP3A4 leaving no active metabolites in the human plasma.
Chemical Structure and
IUPAC name Molecular formula /Molecular weight
IUPAC Name: pregn-4-ene-7,21-dicarboxylic acid, 9,11-epoxy-17-hydroxy-3-oxo, γ-lactone,…show more content… The method development was initiated with solubility study of Eplerenone (10). Based on these studies, Mobile phase-A and Mobile phase-B (70:30) mixture was chosen as diluents for the preparation of samples solutions. From the molecular formula of Eplerenone it was notice that it is polar in nature. A non polar C18 column containing octadecyl chemically bonded to porous silica stationary phase was selected for developing reverse phase high performance liquid chromatogram. Hence there is possibility for its UV–Visible detection. The UV experiment was performed for maximum absorbance of Eplerenone and finally concluded that Eplerenone shows maximum absorbance at…show more content… System suitability solution: Weigh accurately 20.0 mg of Eplerenone working standard into 20ml volumetric flask, add 10mL diluents and dissolved. Further add 1mL of System suitability stock solution and mixed.
Preparation of standard solution:
Weighed accurately 25.0 mg of Eplerenone working standard into a 20 mL volumetric flask, added 10 mL of diluents and dissolved. Further diluted 1 mL to 250 mL.
Sample preparation: Weighed and transferred 10 tablets into 500 mL volumetric flask. Added 250 mL of diluents and sonicated for 15 min and diluted to volume with same diluents and mixed. Filter the solution using 0.22 micron filter. System suitability was studied by injecting diluents as blank, placebo, System suitability solution into the HPLC system and good resolution was obtained between Impurities and Eplerenone. The system suitability results were given below. Table 4.3: System suitability results:
S.No. Resolution
(NLT:2.0) Theoretical plates (NLT:2500) Tailing
(NMT:2-0) %