Article ID Journal Published Year Pages File Type
1223399 Journal of Pharmaceutical and Biomedical Analysis 2009 6 Pages PDF
Abstract

A reversed-phase high-performance liquid chromatographic (HPLC) method was developed and validated for evaluating the chiral discrimination ability of CYCLOBOND I 2000 DM chiral stationary phase (CSP) towards sertraline and its related enantiomers. The effect of pH, buffer concentration as well as nature of organic modifier, flow rate and temperature on enantioselectivity was investigated. The developed reversed-phase chromatographic conditions were able to separate not only the enantiomers of sertraline but also its process related chiral impurities. The method was validated for determination of enantiomeric purity of sertraline HCl in drug substances and formulations.

Related Topics
Physical Sciences and Engineering Chemistry Analytical Chemistry
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