Amaziptin-M 1000 Description

Sitagliptin and Metformin Tablets 50 mg/1 g: Each film-coated tablet contains: Sitagliptin (as hydrochloride) 50 mg, Metformin Hydrochloride 1 g.
Sitagliptin: Sitagliptin is described chemically as 7-[(3R)-3-amino-1-oxo-4-(2,4,5-trifluorophenyl) butyl]-5,6,7,8-tetrahydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3-a]pyrazine hydrochloride monohydrate and the molecular formula is C₁₆H₁₈ClF₆N₅O₂, molecular weight is 461.79.
Sitagliptin is a white to off-white powder and a pKa is 7.80 (By HPLC). It is freely soluble in water, slightly soluble in ethanol.
Metformin Hydrochloride: Metformin Hydrochloride is described chemically as 1, 1-Dimethylbiguanide Hydrochloride N, N-Dimethylimidodicarbonimidicdiamide N'-Dimethylguanyl guanidine and the molecular formula is C₄H₁₁N₅·HCl, molecular weight is 165.62.
Metformin Hydrochloride is a white crystalline powder and a pKa of Metformin HCI has 2 dissociation constants, for which the pK values (at 32°C) have 2.8 and 11.5. It is freely soluble in water, slightly soluble in alcohol, practically insoluble in acetone and in methylene chloride.
Excipients/Inactive Ingredients: Sitagliptin and Metformin Hydrochloride contain the following inactive ingredients: Cellulose Microcrystalline, Sodium lauryl sulphate, Povidone, Purified water, Opadry II White 85F18422, Opadry II Yellow 85F520153.