雷贝拉唑钠肠溶片中1-(1H-苯并咪唑-2-基)-3-甲基-4-氧代-1,4-二氢吡啶-2-羧酸钠的HPLC法测定  

Determination of Sodium 1-(1H-Benzimidazol-2-yl)-3-methyl-4-oxo-1,4-dihydropyridine-2-carboxylate in Rabeprazole Sodium Enteric-coated Tablets by HPLC

作　　者：宋冬梅[1] 刘茜[1] 江文明[1] 杨永健[1] 

机构地区：[1]上海市食品药品检验所,上海201203

出　　处：《中国医药工业杂志》2017年第4期559-563,共5页Chinese Journal of Pharmaceuticals

摘　　要：建立了高效液相色谱法测定雷贝拉唑钠肠溶片中的1-(1H-苯并咪唑-2-基)-3-甲基-4-氧代-1,4-二氢吡啶-2-羧酸钠。采用氨基色谱柱,以0.05 mol/L磷酸二氢钠溶液(用磷酸调至p H 3.0)∶乙腈(60∶40)为流动相,检测波长290 nm。1-(1H-苯并咪唑-2-基)-3-甲基-4-氧代-1,4-二氢吡啶-2-羧酸钠在0.05~20?g/ml浓度范围内线性关系良好,回收率为95.7%,RSD为6.6%。An HPLC method was established for the determination of sodium 1-（1H-benzimidazol-2-yl）-3-methyl-4-oxo-1,4-dihydropyridine-2-carboxylate in rabeprazole sodium enteric-coated tablets. A NH2 column was used with the mobile phase of 0.05 mol/L sodium dihydrogen phosphate solution （adjusted to pH 3.0 with phosphoric acid）∶acetonitrile （60∶40） at the detection wavelength of 290 nm. It was linear for 1-（1H-benzimidazol-2-yl）-3-methyl-4-oxo-1,4-dihydropyridine-2-carboxylate in the range of 0.05—20 μg/ml. The recovery was 95.7%, with RSD of 6.6%.

关 键 词：雷贝拉唑钠 1-(1H-苯并咪唑-2-基)-3-甲基-4-氧代-1 4-二氢吡啶-2-羧酸钠 高效液相色谱 有关物质测定 

分 类 号：TQ460.71[化学工程—制药化工] O657.72[理学—分析化学]