abstract |
The invention relates to a method of obtaining purified pravastatin sodium from a fermentation broth. The inventive method is simple, fast and cost effective and can be easily performed on an industrial scale. According to the invention, the method comprises the following step, namely: formation of a pravastatin-enriched aqueous solution, production and isolation of crude pravastatin sodium or pravastatin calcium, and transformation of same into purified pravastatin sodium by means of suspension in water, adjustment to acid pH, extraction with organic solvent such as methyl isobutyl ketone or ethyl acetate, addition of a carboxylic acid sodium salt solution in low-molecular-weight alcohol, such as sodium octanoate in methanol, and isolation of the filtration-purified pravastatin sodium, thereby producing a pharmaceutical grade end product, with the optional application of a process involving the recrystallisation of the purified pravastatin sodium thus obtained. |