摘要
建立了高效液相色谱法测定雷贝拉唑钠原料药中的7个有关物质。采用C18色谱柱,以15 mmol/L磷酸氢二钠溶液（用磷酸调至p H 6.0）∶乙腈（60∶40）为流动相,检测波长290 nm。雷贝拉唑钠及6个有关物质均在0.04~10μg/ml范围内线性关系良好,另一有关物质2-[（4-甲氧基-3-甲基吡啶-2-基）甲亚磺酰基]-1H-苯并咪唑的线性范围为0.04~5μg/ml。7个有关物质回收率为101.34%~107.90%,RSD为1.00%~6.35%。
An HPLC method was established for the determination of the related substances in rabeprazole sodium bulk drug. A C18 column was used, with the mobile phase of 15 mrnolfL disodium hydrogen phosphate solution （adjusted to pH 6.0 with phosphoric acid） ： acetonitrile （60 ： 40）, at the detection wavelength of 290 nm. The calibration curves of rabeprazole sodium and six related substances were linear in the ranges of 0.04 - 10 μg/ml, while it was linear in the range of 0.04 - 5 μg/ml for 2-[ [ （4-methoxy-3-methylpyridin-2-yl）methyl] sulfinyl]-lH-benzimidazole. The recoveries for seven related substances were 101.34 % - 107.90 %, with RSDs of 1.00 % - 6.35 %.
出处
《中国医药工业杂志》
CAS
CSCD
北大核心
2015年第9期1013-1016,共4页
Chinese Journal of Pharmaceuticals
基金
上海市科学技术委员会项目(11DZ1920907)
