高效液相色谱法测定泰妥拉唑片剂中的有关物质

Detection of related substances by RP-HPLC in tenatoprazole tablets

目的：建立测定泰妥拉唑片中有关物质的高效液相色谱法。方法：采用Diamonsil C18柱(250mm×4．6mm，5μm)，以乙腈-磷酸盐缓冲液(30：70)为流动相，检测波长为306nm，柱温为25℃，流速为1mL·min-1。结果：主药与有关物质达到了较好的分离。测定结果表明3批样品中有关物质含量分别为0．63％，0．71％和0.76％。结论：本方法测定泰妥拉唑片中的有关物质方法简便，结果准确，专属性强。

Objective:To establish a method to determine the related substances in tenatoprazole tablets by RP-HPLC. Methods: The following assay conditions were established: C18 column (250 mm×4.6mm,5μm) as stationary phase;acetonitrile-phosphate buffers solution (30:70) as the mobile phase, and the detection wavelength at 306nm. Results: Separation of tenatoprazole from the related substances was attained. Three batches of samples were tested for the related substances. The result was 0.63% ,0.71 % ,0.76% .respectively. Conclusion:The simple and accurate method can be used to detect the related substances in tenatoprazole tablets.