Fast, simple HPLC method for determination of Spironolactone related compounds

Abstract

Spironolactone is chemically 7α-Acetylthio-17αhydroxy-3-oxopregn-4-ene-21-carboxylic acid γ-lactone. Spironolactone is a steroid and is renal competitive aldosterone antagonist which belongs to the class called potassium-sparing diuretic. Spironolactone acts initially via competitive binding of receptors at the aldosteronedependent sodium-potassium exchange site. This antagonism effect increases the excretion of water and sodium, while decreasing the excretion of potassium (K+ sparing diuretic). Due to this mechanism Spironolactone acts as a diuretic and also as an antihypertensive drug and is indicated for the treatment of congestive heart failure, oedema and ascites in cirrhosis and primary hyperaldosteronism. It is also used for treating hair loss and acne in women, adult acne vulgaris and can be used as a topical medication for treatment of male baldness (Hegazy at al., 2011). We develop and optimize an analytical method for the determination of related substances of Spironolactone that will be time efficient, robust, and with proven performance and the possibility of efficient separation of Spironolactone from the related substances listed as requirements in the monograph for Spironolactone in the European Pharmacopoeia (European Pharmacopoeia, 2023).