气相色谱法用于米诺膦酸关键中间体的质量控制

Quality Control of Key Intermediate of Minodronic Acid by GC

建立了米诺膦酸原料药关键中间体质量控制的毛细管气相色谱测定方法;采用安捷伦DB-624(0.32 mm×30 m,1.8μm)色谱柱,固定液为6%氰丙基苯基-94%二甲基聚硅氧烷,进样口温度为180℃,检测器温度为260℃,柱温箱采用程序升温;经验证,米诺膦酸中间体与各个杂质均能有效分离,该方法简便,灵敏,准确,可有效地控制米诺膦酸关键中间体的质量。

A capillary gas chromatographic method for the quality control of key intermediates of minodronic acid API was established.Agilent DB-624 column(0.32 mm×30 m,1.8μm)was used,the fixed solution was 6%cyanopropyl phenyl-94%dimethyl polysiloxane,the inlet temperature was 180℃,the detector temperature was 260℃,the column temperature was programmed.The results showed that minodronic acid intermediate can be effectively separated from each impurity.the method was simple,sensitive and accurate,and could be used to control the quality of key intermediate of minodronic acid.