Analysis of cis-trans isomers and enantiomers of sertraline by cyclodextrin-modified micellar electrokinetic chromatography

In this work development, optimization and validation of a cyclodextrin-mod ified micellar electrokinetic chromatography (CD-modified MEKC) method is p roposed to resolve separation of the sertraline hydrochloride and synthesis -related substances. Sertraline hydrochloride, the cis-(1S,4S) enantiomer f orm, is used as an antidepressant therapeutic agent. A. buffer concentratio n composed of 20 mM sodium berate, pH 9.0 with 50 mM sodium cholate, 15 mM sulfated beta-cyclodextrin and 5 mM hydroxypropyl-beta-cyclodextrin was fou nd to be the most suitable background electrolyte. Quantitation of the impu rities at levels of 0.1% in different samples of the bulk drug was determin ed. A comparison of the results with those obtained by HPLC methodology was also accomplished. The method proved appropriate for testing the purity of sertraline hydrochloride in bulk drug. (C) 2000 Elsevier Science B.V. All rights reserved.