高效液相法测定泮托拉唑钠肠溶片的有关物质

Determination of Related Substances in Pantoprazole Sodium Enteric-coated Tablets by HPLC

目的:建立泮托拉唑钠肠溶片的有关物质检测方法。方法:HPLC法,色谱柱为Kromasil C18(250mm×4.6mm,5μm),以缓冲液-乙腈(65:35)为流动相;检测波长为290nm;流速1.0ml/min;柱温为30℃;进样量20μl。结果:泮托拉唑钠与各杂质峰分离度良好。结论:本方法能有效的测定泮托拉唑钠肠溶片的有关物质。

Objective：To develop an RP-HPLC method for the determination of related substances in pantoprazole sodium enter- ic-coated tablets. Methods：Chromatographic analysis was performed on Kromasil C18 （250mm × 4.6mm, 5 μm）column with buf- fer-acetonitrile as the mobile phase. The detection wavelength was at 290nm. The flow rate was 1.0 ml. min-1. The column temperature was 30~C, with a 20μl injection volume. Results：Pantoprazole sodium and its related substances could be well separated. Conclu- sion：This method can be applied to determine the related substances of pantoprazole sodium enteric-coated tablets.