雷贝拉唑钠肠溶胶囊(微丸型)的HPLC分析

Determination of Rabeprazole Sodium Enteric-coated Capsules(micro pill)

建立HPLC法测定雷贝拉唑钠肠溶胶囊(微丸型)的有关物质。采用AgilentZORBAX(4.6mm×250mm,5μm)色谱柱,流动相采用0.015mol/L磷酸氢二钠溶液(用磷酸调节pH值至6.0)-乙腈(v∶v=65∶35),等度洗脱,流速为1.0mL/min,柱温:30℃,检测波长为290nm。该色谱条件下,主成份与已知杂质分离度良好。雷贝拉唑钠的检测限为3.3μg/mL,定量限为10μg/mL,是供试品进样量的0.33%和1.00%,满足杂质检测和控制。通过稳定性的考察,供试品溶液不稳定,需要现用现配。该方法简单、快速、准确,可用于雷贝拉唑钠肠溶胶囊(微丸型)的质量控制。

A HPLC method for the determination of related substances in rabeprazole sodium was established.The determination was performed on an AgilentZORBAX（4.6 mm×250 mm, 5 μm） column. The mobile phase consisted of 0.015 mol/L Sodium phosphate dibasic（adjusted p H value 6 with phosphoric acid）-acetonitrile（65：35）. Other conditions for the separation were including isocratic elution, a flow rate of 1 m L/min, column temperature of 30℃,detection wavelength of 290 nm. Ralated substances were completely separated from the main constituent. The detection limit for rabeprazole was 3.3 μg/m L and the quantification limit was 10 μg/m L, which were 0.33% and 1.00% of test sample,respectively. The solution is not stable, it needed to be used at present. The method simple, rapid and accurate, and can be used to control the quality of rabeprazole sodium enteric-coated pellets.