Studies on the separation and purification of tacrolimus
Objective The purpose of this study is to develop a separation and purification process for tacrolimus.Methods Tacrolimus coarse powder with high purity was obtained by ion exchange resin decolorization,nanofiltration and crystallization,which was further refined by reverse phase chromatography silica gel chromatography and composite solution crystallization to obtain the tacrolimus product that can meet USP standards.Results The optimized decolorizing resin was D002.The titer of the tacrolimus coarse powder was more than 800 μg/mg and the purity of the dihydro-tacrolimus was less than 4％.Then we continued to purify the coarse powder using UniSil C8 Ultra Plus chromatography to obtain the fine powder.And the purity of the tacrolimus fine powder was more than 99.5％;the maximum single impurity substance was less than 0.1％.Conclusion This method had the characteristics of simple operation,low energy consumption and high yield,which were of great significance to the industrial production of tacrolimus.
TacrolimusSeparation and purificationIon exchange resinChromatographyCrystallization
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