【摘要】 为优化注射用雷贝拉唑钠有关物质HPLC检测条件,本实验采用岛津LC-10A高效液相色谱仪系统,Shimadzu CLC-ODS色谱柱,流速1.0 mL.min-1,柱温25℃,检测波长为286 nm,流动相采用(c)0.05 mol.L-1磷酸二氢钾缓冲溶液-甲醇-乙腈(50︰30︰20,1.0 mol.L-1氢氧化钾溶液调pH 7.0)对其进行检查。流动相(c)较流动相(a)、(b)而言,主成分峰与杂质峰分离效果佳,专属性强、灵敏度高,适用于注射用雷贝拉唑钠中有关物质的测定。更多还原

【Abstract】 To optimize the method for the determination of related substance in rabeprazole sodium for injection,the experiment was carried out on a LC-10A HPLC system,with the chromatographic column of Shimadzu CLC-ODS,the flow rate at 1.0 mL·min-1,the column temperature at 25 ℃,using the mobile phase(c) 0.05 mol·L-1 potassium dihydrogen phosphate-methanol-acetonitrile(50︰30 ︰20) with the pH adjusted to 7.0 using 1.0 mol·L-1 potassium hydroxide.Comparing with(a) or(b),under mobile phase(c) the main peak of ingredient was well separated from impurities.This column condition showed exclusive property and high sensitivity,it is applicable to determine rabeprazole sodium for injection and related substances.更多还原