Separation of stereoisomers of sertraline and its related enantiomeric impurities on a dimethylated beta-cyclodextrin stationary phase by HPLC.
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.
Rao
R Nageswara
RN
Analytical Chemistry Division, Discovery Laboratory, Indian Institute of Chemical Technology, Tarnaka, Hyderabad 500 607, India. rnrao55@yahoo.com
Talluri
M V N Kumar
MV
Maurya
Pawan K
PK
D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D006863:Hydrogen-Ion Concentration; D017367:Selective Serotonin Reuptake Inhibitors / Q000032:analysis* / Q000737:chemistry; D020280:Sertraline / Q000032:analysis* / Q000737:chemistry; D013237:Stereoisomerism; D013696:Temperature; D047392:beta-Cyclodextrins
D017367:Selective Serotonin Reuptake Inhibitors; D020280:Sertraline; D047392:beta-Cyclodextrins; C038119:heptakis(2,6-O-dimethyl)beta-cyclodextrin