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

被引：33
作者：
Rao, R. Nageswara [1 ]
Talluri, M. V. N. Kumar [1 ]
Maurya, Pawan K. [1 ]
机构：
[1] Indian Inst Chem Technol, Div Analyt Chem, Discovery Lab, Hyderabad 500607, Andhra Pradesh, India
来源：
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS | 2009年 / 50卷 / 03期
关键词：
Selective serotonin reuptake inhibitors (SSRI); Antipsychotics; Sertraline HCl; Inclusion complexes; Enantiomeric purity; Dimethylated beta-cyclodextrin; CHROMATOGRAPHY MASS-SPECTROMETRY; LIQUID-CHROMATOGRAPHY; BONDED-PHASE; RETENTION; PURITY; ASSAY; DRUG; PH;
D O I：
10.1016/j.jpba.2009.04.038
中图分类号：
O65 [分析化学];
学科分类号：
070302 ; 081704 ;
摘要：
A reversed-phase high-performance liquid chromatographic (HPLC) method was developed and validated for evaluating the chiral discrimination ability of CYCLOBOND I 2000 DIM 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. (C) 2009 Published by Elsevier B.V.
引用
收藏
页码：281 / 286
页数：6
相关论文
共 20 条
  • [1] Assay of sertraline in tablets and drug substance by liquid chromatography
    Adams, AIH
    Bergold, AM
    [J]. JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS, 2001, 26 (03) : 505 - 508
  • [2] EVALUATION OF THE EFFECT OF ORGANIC MODIFIER AND PH ON RETENTION AND SELECTIVITY IN REVERSED-PHASE LIQUID-CHROMATOGRAPHIC SEPARATION OF ALKALOIDS ON A CYCLODEXTRIN BONDED PHASE
    ARMSTRONG, DW
    BERTRAND, GL
    WARD, KD
    WARD, TJ
    SECOR, HV
    SEEMAN, JI
    [J]. ANALYTICAL CHEMISTRY, 1990, 62 (04) : 332 - 338
  • [3] BEESLEY TE, 2001, LC GC EUR, V16, P16
  • [4] Simultaneous determination of human plasma levels of citalopram, paroxetine, sertraline, and their metabolites by gas chromatography mass spectrometry
    Eap, CB
    Bouchoux, G
    Amey, M
    Cochard, N
    Savary, L
    Baumann, P
    [J]. JOURNAL OF CHROMATOGRAPHIC SCIENCE, 1998, 36 (07) : 365 - 371
  • [5] GAS-CHROMATOGRAPHIC MASS-SPECTROMETRIC ANALYSIS AND PRELIMINARY HUMAN PHARMACOKINETICS OF SERTRALINE, A NEW ANTIDEPRESSANT DRUG
    FOUDA, HG
    RONFELD, RA
    WEIDLER, DJ
    [J]. JOURNAL OF CHROMATOGRAPHY-BIOMEDICAL APPLICATIONS, 1987, 417 (01): : 197 - 202
  • [6] The role of cyclodextrins in chiral selective chromatography
    Juvancz, Z
    Szejtli, J
    [J]. TRAC-TRENDS IN ANALYTICAL CHEMISTRY, 2002, 21 (05) : 379 - 388
  • [7] Kudo K, 2000, ENANTIOMER, V5, P369
  • [8] Effect of the eluent pH and acidic modifiers in high-performance liquid chromatography retention of basic analytes
    LoBrutto, R
    Jones, A
    Kazakevich, YV
    McNair, HM
    [J]. JOURNAL OF CHROMATOGRAPHY A, 2001, 913 (1-2) : 173 - 187
  • [9] McIntyre IM, 1997, J FORENSIC SCI, V42, P951
  • [10] SERTRALINE - A REVIEW OF ITS PHARMACODYNAMIC AND PHARMACOKINETIC PROPERTIES, AND THERAPEUTIC POTENTIAL IN DEPRESSION AND OBSESSIVE-COMPULSIVE DISORDER
    MURDOCH, D
    MCTAVISH, D
    [J]. DRUGS, 1992, 44 (04) : 604 - 624
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