TITLE OF THE INVENTION SALT OF l,2,6,7,8,8A-HEXAHYDRO-β,δ,6- TRIHYDROXY-2-METHYL-8-[(2S)-2-METHYL-l- OXOBUTOXY]-, (βR,δR,lS,2S,6S,8S,8AR)- 1- NAPHTHALENEHEPTANOIC ACID WITH N,N-DIMETHYL- IMIDODICARBONIMIDIC DIAMIDE FIELD OF THE INVENTION This invention relates to a novel compound of formula I, wherein the compound is used for treating hyperlipidemia and hyperglycemia. BACKGROUND OF THE INVENTION Hyperlipidemia is generally accompanied by other disorders of heart, kidney, stomach or liver. Hyperlipidemia is treated employing l,2,6,7,8,8a-hexahydro-β,δ,6-trihydroxy-2-methyl-8- [(2s)-2-methyl-l-oxobutoxy]-, (βR,δ ,lS,2S,6S,8S,8aR)- 1- naphthaleneheptanoic acid, sodium salt so that active, open acid form is made available. Antihyperglycemic agents are used for treatment of diabetes. N,N -dimethyl- imidodicarbonimidic diamide is used for treatment of Non-insulin dependent diabetes mellitus (NIDDM). N,N-dimethyl- imidodicarbonimidic diamide is generally administered as HCI salt. The present invention discloses a novel compound of formula I, which is a salt of l,2,6,7,8,8a-hexahydro-β,δ,6-trihydroxy-2- methyl-8-[(2s)-2-methyl-l-oxobutoxy]-, (βR,δR,lS,2S,6S,8S,8aR)- 1-naphthaleneheptanoic acid with N,N-dimethyl- imidodicarbonimidic diamide and can be used for simultaneous treatment of hyperlipidemia and diabetes.
SUMMARY OF THE INVENTION The present invention discloses a novel compound of formula I. The compound can be used for treating hyperlipidemia and hyperglycemia.
FORMULA I It is mutual salt of two drugs viz. l,2,6,7,8,8a-hexahydro- β,δ,6-trihydroxy-2-methyl-8-[(2s)-2-methyl-l-oxobutoxy]-, (βR,δR,lS,2S,6S,8S,8aR)- 1-naphthaleneheptanoic acid and N,N- dimethyl- imidodicarbonimidic diamide. DETAILED DESCRIPTION OF THE INVENTION The present invention discloses a novel compound (FORMULA I) which is a salt of l,2,6,7,8,8a-hexahydro-β,δ,6-trihydroxy-2- methyl-8-[(2s)-2-methyl-l-oxobutoxy]-, (βR,δR,lS,2S,6S,8S,8aR)- 1-naphthaleneheptanoic acid with N,N-dimethyl- imidodicarbonimidic diamide. Compound of formula I can be used for treating hyperlipidemia and hyperglycemia.
FORMULA I The important embodiment of the present invention is that the compound of formula I, wherein the mutual salt which can be called xN,N-dimethyl- imidodicarbonimidic diamide salt of l,2,6,7,8,8a-hexahydro-β,δ,6-trihydroxy-2-methyl-8-[(2s)-2-methyl- 1-oxobutoxy]-, (βR,δR,lS,2S,6S,8S,8aR)- 1-naphthaleneheptanoic acid. The invention discloses the compound of formula I, wherein the l,2,6,7,8,8a-hexahydro-β,δ,6-trihydroxy-2-methyl-8-[(2s)-2- methy I- 1-oxobutoxy]-, (βR,δR,lS,2S,6S,8S,8aR)- 1- naphthaleneheptanoic acid is an anticholesterolemic or antilipidemic drug and N,N-dimethyl- imidodicarbonimidic diamide is an antihyperglycemic drug. The compound of formula I is formed when a non-covalent bond between the carboxylic group of l,2,6,7,8,8a-hexahydro- β.δ,6-trihydroxy-2-methyl-8-[(2s)-2-methyl-l-oxobutoxy]-, (βR,δR,lS,2S,6S,8S,8aR)- 1-naphthaleneheptanoic acid and
5 nitrogen of N,N-dimethyl- imidodicarbonimidic diamide. Preferably, the non-covalent bond thus formed is an ionic bond between l,2,6/7,8,8a-hexahydro-β,δ,6-trihydroxy-2-methyl-8-[(2s)-2-methyl- 1-oxobutoxy]-, (βR,δR,lS,2S,6S,8S,8aR)- 1-naphthaleneheptanoic acid and N,N-dimethyl- imidodicarbonimidic diamide. The
10 compound of formula I is a mutual salt of l,2,6,7,8,8a-hexahydro- β,δ,6-trihydroxy-2-methyl-8-[(2s)-2-methyl-l-oxobutoxy]-, (βR,δR,lS,2S,6S,8S,8aR)- 1-naphthaleneheptanoic acid and N,N- dimethyl- imidodicarbonimidic diamide. Like any metal salt of l,2,6,7,8,8a-hexahydro-β,δ,6- i5 trihydroxy-2-methyl-8-[(2s)-2-methyl- 1-oxobutoxy]-, (βR,δR,lS,2S,6S,8S,8aR)- 1-naphthaleneheptanoic acid, compound of formula I retain the open chain active form of 1,2,6,7,8,8a- hexahydro-β,δ,6-trihydroxy-2-methyl-8-[(2s)-2-methyl-l- oxobutoxy]-, (βR,δR,lS,2S,6S,8S,8aR)- 1-naphthaleneheptanoic
20 acid and prevent formation of undesired inactive lactone derivative. Compound of formula I also have the extra advantage of delivering the active open acid form of l,2,6,7,8,8a-hexahydro- β,δ,6-trihydroxy-2-methyl-8-[(2s)-2-methyl- 1-oxobutoxy]-, (βR,δR,lS,2S,6S,8S,8aR)- 1-naphthaleneheptanoic acid without
25 employing any metal cation. Unlike prior art, compound of formula I deliver N,N-dimethyl- imidodicarbonimidic diamide free-base without employing any other acid salt like hydrochloride salt. ' Formation of a mutual salt enhances solubility of both the
3o drugs in water and aqueous media without the aid of any further derivatisation.
5 The following non-limiting examples illustrate the inventors' preferred method for preparing the compound of the invention. EXAMPLES Example 1 To a solution of l,2,6,7,8,8a-hexahydro-β,δ,6-trihydroxy-2- ιo methyl-8-[(2s)-2-methyl-l-oxobutoxy]-, (βR,δR,lS,2S,6S,8S,8aR)- 1-naphthaleneheptanoic acid (5 g, 0.012 mol) in ethyl acetate (75 ml), N,N-dimethyl- imidodicarbonimidic diamide free base (1.5 g, 0.012 mol) was added and stirred. The reaction mixture was chilled (10-15° C) to afford the mutual salt.of l,2,6,7,8,8a-hexahydro- i5 β,δ,6-trihydroxy-2-methyl-8-[(2s)-2-methyl-l-oxobutoxy]-, (βR,δR7lS,2S,6S,8S,8aR)- 1-naphthaleneheptanoic acid and N,N- dimethyl- imidodicarbonimidic diamide. Example 2 To a solution of l,2,6,7,8,8a-hexahydro-β,δ,6-trihydroxy-2-
20 methyl-8-[(2s)-2-methyl-l-oxobutoxy]-, (βR,δR,lS,2S,6S,8S,8aR)- 1-naphthaleneheptanoic acid (10 g, 0.024 mol) in isobutyl acetate (200 ml), N,N-dimethyl- imidodicarbonimidic diamide free base (3 g, 0.024 mol) was added and stirred. The reaction mixture chilled (10-15° C) to afford the mutual salt of l,2,6,7,8,8a-hexahydro-
25 β,δ,6-trihydroxy-2-methyl-8-[(2s)-2-methyl- 1-oxobutoxy]-, (βR,δR,lS,2S,6S,8S,8aR)- 1-naphthaleneheptanoic acid and N,N- dimethyl- imidodicarbonimidic diamide.