埃索美拉唑钠中间体清洁验证残留限度检查方法学研究

摘要

目的：埃索美拉唑钠合成中间体清洁验证残留限度检查方法学研究。方法：色谱柱为Agilent ZORBAX SB-C18，4.6mm×150mm，5μm；以乙腈-磷酸盐缓冲液（pH7.6）（50∶50）为流动相；流速1.0mL·min-1；检测波长302nm；进样量10μL。结果：中间体的线性范围为0.06μg·mL-1～1.5μg·mL-1；定量限和检出限分别为0.24ng和0.08ng；平均回收率为89.29%，RSD为1.8%。结论：本方法简便、快速、准确、精密度高、回收率好，可用于中间体的清洁验证。%Objective:the methodology of cleaning validation for esomeprazole sodium mediate limite determination. Methods:The ostadecylsilane column (Agilent ZORBAX SB-C18,4.6mm×150mm,5μm)was used,the mobile phase was acetonitrile-phosphate buffered solution (pH 7.6)(50∶50),the flow rate was 1.0mL·min-1,the detection wavelength was 302nm,the injection volume was 10μL. Results:The linear range for intermediate was 0.06μg·mL-1~1.5μg·mL-1.The limit of quantitation and the detection limit were 0.24ng and 0.08ng.The average recovery rate was 89.29%with RSD1.8%.Conclusion:This is a convenient, rapid, accurate, high precision and good recovery method, which can be used for the cleaning validation of intermediate.