Determination of ethyl p - toluenesulfonate in Citalopram Hydrobromide by HPLC
SUN Pu
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.
Keywords：HPLCCitalopram HydrobromideGenotoxic impurityEthyl p - toluenesulfonate
Publication Date：2015-01-01
Online Publishing Date：2025-08-15(First online date of this platform, not the publication date of the document)
Pages：3( 637-639 )