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UHPLC Determination of Enantiomeric Purity of Sertraline in the Presence of its Production Impurities

Chromatographia volume 77, pages 1315–1321 (2014)Cite this article

Abstract

A fast and low reagents consuming ultra-high performance liquid chromatography method was developed for the determination of the enantiomeric purity of sertraline in presence of its stereoisomers and four other process-related chiral impurities. The optimum chromatographic conditions were achieved using a commercially available C8 column with sub-2-μm particle size, and a mobile phase of 10 mM tetrabutylammonium hydrogen sulfate buffer pH = 3-acetonitrile (87:13, v/v) and 12 mM 2-hydroxypropyl-β-cyclodextrin as chiral additive, with ultraviolet detection at 220 nm. The method was validated in terms of ruggedness, specificity, linearity, accuracy, precision, and limits of detection and quantification. Different variables affecting the enantioresolution and retention time were optimized, such as pH, buffer concentration and type, chiral additive concentration and type, flow rate, stationary phase, mobile phase, and column temperature. Total analysis time was reduced by 50 % compared with conventional HPLC; also 94 % of acetonitrile and 90 % of 2-hydroxypropyl-β-cyclodextrin were saved.

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Acknowledgments

Authors thank Signa S. A. de C. V., for the materials and instrumentation used during the development of this work. HRP acknowledge the Grant from CONACYT.

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Authors and Affiliations

  1. Centro Conjunto de Investigación En Química Sustentable UAEM-UNAM, Km 14.5 Carretera Toluca-Atlacomulco, Campus UAEMex “El Rosedal” San Cayetano, C.P. 50200, Toluca, Estado de México, Mexico

    M. L. Reyes-Reyes, Gabriela Roa-Morales & Patricia Balderas-Hernández

  2. Departamento de Investigación Y Desarrollo, Signa, S.A. de C.V., Av. Industria Automotriz No. 301, Zona Industrial Toluca, 50071, Toluca, Estado de México, Mexico

    M. L. Reyes-Reyes & Roberto Melgar-Fernández

  3. Facultad de Química, Universidad Autónoma Del Estado de México, Avenida Paseo Tollocan S/N, 50180, Toluca, Estado de México, Mexico

    Horacio Reyes-Pérez

Authors
  1. M. L. Reyes-Reyes
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  2. Gabriela Roa-Morales
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  3. Roberto Melgar-Fernández
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  4. Horacio Reyes-Pérez
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  5. Patricia Balderas-Hernández
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Correspondence to M. L. Reyes-Reyes.

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Reyes-Reyes, M.L., Roa-Morales, G., Melgar-Fernández, R. et al. UHPLC Determination of Enantiomeric Purity of Sertraline in the Presence of its Production Impurities. Chromatographia 77, 1315–1321 (2014). https://doi.org/10.1007/s10337-014-2744-3

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  • DOI: https://doi.org/10.1007/s10337-014-2744-3

Keywords

  • Ultra-high performance liquid chromatography
  • Cyclodextrins
  • Sertraline
  • Chiral mobile phase additives