摘要
Abstract
Objective To establish an HPLC method for the determination of genotoxic impurity ethyl p - toluenesul-fonate in Citalopram Hydrobromide. Methods The method was achieved on a Agilent Zorbax SB - C18 column(4. 6 mm × 150 mm,5 μm)utilizing a mobile phase of acetonitrile - buffer(0. 02 mol·L - 1 phosphate buffered solution,adjusting pH to 3. 5 with phosphoric acid)(50:50)at the flow rate of 1. 0 mL·min - 1 and the wavelength was 225 nm. Results Stand-ard curve was linear in the range of 0. 025 6 ~ 0. 187 5 μg·mL - 1(R2 = 0. 999 3). The precision was good,and RSD was 0. 8% . The values of limit of quantification and limit of detection were 0. 025 6 μg·mL - 1 and 0. 012 4 μg·mL - 1 ,respec-tively. The recovery of ethyl p - toluenesulfonate in Citalopram Hydrobromide was 101. 4% . Conclusion The method was convenient,fast and precise. It can determine ethyl p - toluenesulfonate in Citalopram Hydrobromide accurately.关键词
高效液相色谱法/氢溴酸西酞普兰/基因毒性杂质/对甲苯磺酸乙酯Key words
HPLC/Citalopram Hydrobromide/Genotoxic impurity/Ethyl p - toluenesulfonate分类
医药卫生
