QUANTIFICATION OF SPIRONOLACTONE AND ITS IMPURITIES PRESENT IN PHARMACEUTICAL DOSAGE FORMS BY STABILITY-INDICATING HPLC METHODAbstract
Spironolactone belongs to a group of medicine known as aldosterone antagonist used as sparing diuretic, Spironolactone (aldactone) is potassium -aspiring diuretic agent and has half-life of about 16 hours. Spironolactone one diuretics agents which increases renal excretion of water and solutes (mainly sodium salt). It is used mainly in the treatment of refractory edema in patients with congestive heart failure nephrotic syndrome, or hepatic cirrhosis. On its own, spironolactone is only a weak diuretic, but it can be combined with other diuretics. Spironolactone is 7α-acetyle thio-3-oxo-17α-pregn-4-ene-21,17β- carbolactone. Its molecular formula is C24 H32O4S having a molecular weight 416.58 gm/mole. The possible related compound (degradants and process-related impurities) as Spironolactone related compound –A of Spironolactone having chemical names are S-((2’R, 7R, 8R, 9S, 10R, 13S, 14S)-10, 13-Dimethyl-3, 5′-dioxo-1, 2, 3, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16-tetradecahydro-5’H-spiro[cyclopenta[a]phenanthrene-17,2′-furan]-7-yl) ethanethioate.
Amit S. Tapkir *, Harshal S. Loharkar and Santaji Nalawade
PES Modern College of Pharmacy, Nigdi, Pune, Maharashtra, India.
25 July 2022
30 September 2022
28 February 2023
01 April 2023