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Epoxide-derived mixed-mode chromatographic stationary phases for separation of active substances in fixed-dose combination drugs.

Abstract

A method for the preparation of novel mixed-mode reversed-phase/strong cation exchange stationary phase for the separation of fixed-dose combination drugs has been developed. An epoxysilane bonded silica prepared by vapor phase deposition was used as a starting material to produce diol, octadecyl, sulfonate, and mixed octadecyl/sulfonate groups bonded silica phases. The chemical structure and surface coverage of the functional groups on these synthesized phases were confirmed by fourier-transform infrared and solid-state 13 C NMR spectroscopy and elemental analysis. Alkylbenzene homologs, basic drugs, nucleobases and alkylaniline homologs were used as probes to demonstrate the reversed-phase, ion exchange, hydrophilic interaction and mixed-mode retention behaviors of these stationary phases. The octadecyl/sulfonate bonded silica exhibits pronounced mixed-mode retention behavior and superior retentivity and selectivity for alkylaniline homologs. The mixed-mode retention is affected by either ionic or solvent strength in the mobile phase, permiting optimization of a separation by fine tuning these parameters. The mixed-mode stationary phase was applied to separate two fixed-dose combination drugs: compound reserpine tablets and compound methoxyphenamine capsules. The results show that simultaneous separation of multiple substances in the compound dosage can be achieved on the mixed-mode phase, which makes multi-cycles of analysis for multiple components obsolete.

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  • Authors+Show Affiliations

    ,

    School of Pharmaceutical Science & Technology, Tianjin University, Tianjin, P. R. China.

    ,

    School of Pharmaceutical Science & Technology, Tianjin University, Tianjin, P. R. China.

    School of Pharmaceutical Science & Technology, Tianjin University, Tianjin, P. R. China.

    Source

    Pub Type(s)

    Journal Article

    Language

    eng

    PubMed ID

    31222942

    Citation

    Zhang, Shuanghong, et al. "Epoxide-derived Mixed-mode Chromatographic Stationary Phases for Separation of Active Substances in Fixed-dose Combination Drugs." Journal of Separation Science, 2019.
    Zhang S, Wan QH, Li Y. Epoxide-derived mixed-mode chromatographic stationary phases for separation of active substances in fixed-dose combination drugs. J Sep Sci. 2019.
    Zhang, S., Wan, Q. H., & Li, Y. (2019). Epoxide-derived mixed-mode chromatographic stationary phases for separation of active substances in fixed-dose combination drugs. Journal of Separation Science, doi:10.1002/jssc.201900307.
    Zhang S, Wan QH, Li Y. Epoxide-derived Mixed-mode Chromatographic Stationary Phases for Separation of Active Substances in Fixed-dose Combination Drugs. J Sep Sci. 2019 Jun 20; PubMed PMID: 31222942.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Epoxide-derived mixed-mode chromatographic stationary phases for separation of active substances in fixed-dose combination drugs. AU - Zhang,Shuanghong, AU - Wan,Qian-Hong, AU - Li,Yan, Y1 - 2019/06/20/ PY - 2019/03/26/received PY - 2019/06/01/revised PY - 2019/06/19/accepted PY - 2019/6/22/pubmed PY - 2019/6/22/medline PY - 2019/6/22/entrez KW - basic compounds KW - fixed-dose combinations KW - mixed-mode chromatography KW - retention mechanisms KW - stationary phases JF - Journal of separation science JO - J Sep Sci N2 - A method for the preparation of novel mixed-mode reversed-phase/strong cation exchange stationary phase for the separation of fixed-dose combination drugs has been developed. An epoxysilane bonded silica prepared by vapor phase deposition was used as a starting material to produce diol, octadecyl, sulfonate, and mixed octadecyl/sulfonate groups bonded silica phases. The chemical structure and surface coverage of the functional groups on these synthesized phases were confirmed by fourier-transform infrared and solid-state 13 C NMR spectroscopy and elemental analysis. Alkylbenzene homologs, basic drugs, nucleobases and alkylaniline homologs were used as probes to demonstrate the reversed-phase, ion exchange, hydrophilic interaction and mixed-mode retention behaviors of these stationary phases. The octadecyl/sulfonate bonded silica exhibits pronounced mixed-mode retention behavior and superior retentivity and selectivity for alkylaniline homologs. The mixed-mode retention is affected by either ionic or solvent strength in the mobile phase, permiting optimization of a separation by fine tuning these parameters. The mixed-mode stationary phase was applied to separate two fixed-dose combination drugs: compound reserpine tablets and compound methoxyphenamine capsules. The results show that simultaneous separation of multiple substances in the compound dosage can be achieved on the mixed-mode phase, which makes multi-cycles of analysis for multiple components obsolete. SN - 1615-9314 UR - https://www.unboundmedicine.com/medline/citation/31222942/Epoxide-derived_mixed-mode_chromatographic_stationary_phases_for_separation_of_active_substances_in_fixed-dose_combination_drugs L2 - https://doi.org/10.1002/jssc.201900307 DB - PRIME DP - Unbound Medicine ER -