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Cefuroxime axetil-3-ene isomer preparation method
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Paragraph 0019-0034, (2020/01/03)
The invention relates to a cefuroxime axetil-3-ene isomer preparation method, and belongs to medicine quality research, quality control and safety research of pharmaceutical enterprises. The steps comprise: (1) in an aprotic solvent and a protic solution, generating a 3-ene isomeric cefuroxime axetil and cefuroxime axetil mixture from cefuroxime axetil under the catalytic action of an alkali; and(2) purifying the 3-ene isomeric cefuroxime axetil and cefuroxime axetil mixture obtained in the step (1) through reversed-phase C18 column preparative liquid chromatography, extracting, drying, andconcentrating to obtain the cefuroxime axetil-3-ene isomer, wherein the chromatographic conditions of purifying comprise that a ratio of water to methanol is 40/60, the flow rate is 40 ml/min, and theultraviolet detection wavelength is 23 nm. According to the invention, the method has advantages of simple reaction operation, mild conditions and high product purity, and the obtained cefuroxime axetil-3-ene isomer can be used as a standard substance in quality control of cefuroxime axetil bulk drugs and preparations.