Objective The process on separation and purification of Dalfopristin with macroporous resins was studied to obtain high quality product for pharmaceutics. Methods HPLC method was setup to detect the purity of dalfopristin in order to study the absorption and desorption performance of resins. Then, the loading amount and desorption conditions were optimized based on the value of desorption rate and purity of Dalfopristin. Results According to experimental data, the most suitable resin is H-60, a domestic macroporous resin with 20mg/ml as the maximum loading amount. The desorption solvent is 12% acetonitrile (ACN) in methyl sulfonic acid (MeSO3H) aqueous solution with pH equal to 3.0. Under these conditions, desorption rate is more than 90%; the purity of final product is above 99.5% at same time. Conclusion This process is applicable for industrial production and preparation of dalfopristin with high purity and desorption rate.%目的 研究大孔吸附树脂法分离纯化达福普汀的工艺条件,以得到高纯度药用级达福普汀.方法 建立HPLC检测方法,考察树脂对达福普汀的吸附和解吸性能,以达福普汀解吸率和纯度为指标,优化上样量和解吸条件等工艺参数.结果 筛选出国产H-60型树脂纯化达福普汀,最大上样量20mg/mL湿树脂,解吸溶剂为12％乙腈的pH=3.0的甲烷磺酸水溶液,解吸率90％以上,成品纯度可达99.5％以上.结论 该工艺纯化效果好,解吸率高,适用于高纯度达福普汀的制备及工业化生产.
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