FIELD: organic chemistry, chemical technology, pharmacy.
SUBSTANCE: invention relates to the improved method for isolating and purifying pravastatin or its pharmacologically acceptable salt from impurities of pravastatin analogues. Method involves extraction of pravastatin or its pharmacologically acceptable salt comprising impurities of pravastatin analogues with organic solvent of the formula: CH3CO2R wherein R represents alkyl comprising 3 or 4 carbon atoms. Also, invention relates to the improved method for isolating or purifying pravastatin or its pharmacologically acceptable salt that involves decomposition of impurities by using inorganic acid or that involves removing compound of the formula (I): by using inorganic solvent. Also, invention relates to the composition comprising pravastatin sodium salt and compound of the formula (I) taken in the amount 0.1 wt.-% or less with respect to the amount of pravastatin sodium salt. Method provides preparing the end product of the high purity degree.
EFFECT: improved purifying method.
18 cl, 1 tbl, 8 ex
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Authors
Dates
2005-09-20—Published
2001-10-15—Filed