Process for the preparation of Trisodium (4- {[1S,3R)-1-([1,1′-biphenyl]-4-ylmethyl)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4-oxobutanoate)-(N-petanoyl-N-{[2′-(1H-tetrazol-1-1D-5-yl)[1,1′-biphenyl]-4-yl]methyl}- L-valinate) and its polymorphs thereof
AssigneeMsn Laboratories Private Limited
InventorsThirumalai Rajan Srinivasan, Eswaraiah Sajja, Rajeshwar Reddy Sagyam, Rajesham Boge, Chkradhar Nandigama, Srinivasa Rao Ambati
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Abstract
The present invention relates to a process for the preparation of Trisodium (4-{[(1S.3R)-1-([1,1′-biphenyl]-4-yl-methyl)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4-oxo butanoate)-(N-pentanoyl-N-{[2′-(1H-tetrazol-1-id-5-yl)[1,1′-biphenyl]-4-yl]methyl}-L-valinate) represented by the following structural formula-1:
Claims12
A process for the preparation of trisodium (4-{[(1S,3R)-1-([1,1′-biphenyl]-4-ylmethyl)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4-oxobutanoate)-(N-pentanoyl-N-{[2′-(1H-tetrazol-1-id-5-yl)[1,1′-biphenyl]-4-yl]methyl}-L-valinate) compound of formula-1,
- comprising:
- a) reacting mono sodium salt of 4-(((2S,4R)-1-([1,1′-biphenyl]-4-yl)-5-ethoxy-4-methyl-5-oxopentan-2-yl)amino)-4-oxobutanoic acid of formula-6
- with disodium salt of (S)-2-(N-((2′-(1H-tetrazol-5-yl)-[1,1′-biphenyl]-4-yl)methyl)pentanamido)-3-methylbutanoic acid of formula-7
- in a solvent,
- b) obtaining trisodium salt of (4-{[(1S,3R)-1-([1,1′-biphenyl]-4-ylmethyl)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4-oxobutanoate)-(N-pentanoyl-N-{[2′-(1H-tetrazol-1-id-5-yl)[1,1′-biphenyl]-4-yl]methyl}-L-valinate) of formula-1 by removal of the solvent.
A Crystalline Form-S of trisodium (4-{[(1S,3R)-1-([1,1′-biphenyl]-4-ylmethyl)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4-oxobutanoate)-(N-pentanoyl-N-{[2′-(1H-tetrazol-1-id-5-yl)[1,1′-biphenyl]-4-yl]methyl}-L-valinate) of formula-1, having an X-ray powder diffraction pattern showing characteristic peaks at 3.1, 4.6, 9.2 and 11.80±0.2° 2-theta.
Dependencies are inferred from the claim text.