采用新型混合模式色谱柱HPLC法测定利伐沙班中残留的乙酸  

Determination of Residual Acetic Acid in Rivaroxaban by HPLC with the New Mixed-Mode Column

作　　者：王雪萍[1] 崔锋[1] 郑台[1] 

机构地区：[1]中国医药工业研究总院上海医药工业研究院创新药物与制药工艺国家重点实验室,上海200040

出　　处：《中国医药工业杂志》2015年第6期623-625,共3页Chinese Journal of Pharmaceuticals

摘　　要：采用新型混合模式色谱柱Dionex Acclaim Mixed-Mode WAX-1，建立了高效液相色谱法测定利伐沙班中的残留溶剂乙酸。流动相为乙腈：O．025mol／L磷酸二氢钾溶液（50：50），检测波长为210nm，以外标法计算。乙酸在1～10μg／ml范围内线性关系良好，平均回收率为100．6％，RSD为0．10％。An HPLC method was established for the determination of residual acetic acid in rivaroxaban using the new mixed-mode column, Dionex Acclaim~ Mixed-Mode WAX-l, with the mobile phase of acetonitrile ; 0.025 mol/L potassium dihydrogen phosphate solution （50 ： 50）, at the detection wavelength of 210 nm. The content of acetic acid was calculated by external standard method. The calibration curve was linear in the concentration range of 1 - 10 μg/ml. The average recovery was 100.6 %, with RSD of 0.10 %.

关 键 词：利伐沙班 乙酸 高效液相色谱 测定 

分 类 号：R917[医药卫生—药物分析学] O657.72[医药卫生—药学]