Journal
JOURNAL OF CHROMATOGRAPHY A
Volume 871, Issue 1-2, Pages 207-215Publisher
ELSEVIER
DOI: 10.1016/S0021-9673(99)00881-X
Keywords
enantiomer separation; sertraline; cyclodextrins
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In this work development, optimization and validation of a cyclodextrin-modified micellar electrokinetic chromatography (CD-modified MEKC) method is proposed to resolve separation of the sertraline hydrochloride and synthesis-related substances. Sertraline hydrochloride, the cis-(1S,4S) enantiomer form, is used as an antidepressant therapeutic agent. A. buffer concentration 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 found to be the most suitable background electrolyte. Quantitation of the impurities at levels of 0.1% in different samples of the bulk drug was determined. 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.
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