Separation of stereoisomers of sertraline and its related enantiomeric impurities on a dimethylated beta-cyclodextrin stationary phase by HPLC.

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.

journal_name

J Pharm Biomed Anal

authors

Rao RN,Talluri MV,Maurya PK

doi

10.1016/j.jpba.2009.04.038

subject

Has Abstract

pub_date

2009-10-15 00:00:00

pages

281-6

issue

3

eissn

0731-7085

issn

1873-264X

pii

S0731-7085(09)00222-2

journal_volume

50

pub_type

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