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 Analjournal_title
Journal of pharmaceutical and biomedical analysisauthors
Rao RN,Talluri MV,Maurya PKdoi
10.1016/j.jpba.2009.04.038subject
Has Abstractpub_date
2009-10-15 00:00:00pages
281-6issue
3eissn
0731-7085issn
1873-264Xpii
S0731-7085(09)00222-2journal_volume
50pub_type
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