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Simultaneous Chemo/Enantioseparation and Assay of R-(+)-Rabeprazole and Related Impurities in Pharmaceutical Formulations

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Abstract

Simultaneous chiral and chemoseparation of R-(+)-rabeprazole and related (enantio)impurities was achieved on a cellulose tris-(3,5-dichlorophenylcarbamate) stationary phase chemically bonded to silica gel (Chiralpak IC). A gradient elution was applied in the reverse-phase separation mode. The mobile phase consisted of a mixture of acetonitrile and aqueous phosphate buffer at pH 7. The other operational parameters were flow rate of 1 mL min−1, column temperature of 35 °C and ultraviolet (UV) detection at 282 nm. Quantification limits for R-(+)-rabeprazole and the related impurities ranged in the interval of 0.02–0.03 %. Linear response intervals of 0.02–0.66 % were obtained with UV detection. Validation of the proposed method was achieved according to current regulations in force. For better understanding of the R-(+)-rabeprazole impurity profile, (+)-EMS/MS and MS/MS detection were also used.

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Acknowledgments

The authors wish to thank the management of Cipla Ltd. for supporting this work. They extend their gratitude to Mr. P. L. Srinivas and other colleagues from R&D unit of Cipla Ltd., Bangalore, India.

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Authors and Affiliations

  1. Department of Chemistry, Sathyabama University, Jeppiar Nagar, Chennai, 600 119, Tamil Nadu, India

    P. Balamurugan

  2. Department of Chemistry, C. Abdul Hakeem College, Melvisharam, 632 509, Tamil Nadu, India

    K. Anver Basha

  3. Analytical Research and Development Department, Cipla Ltd., Bangalore, 560 049, Karnataka, India

    P. Balamurugan, Jeenet Jayachandran & Manish Gangrade

  4. Centre for Research and Development, PRIST University, Thanjavur, 613 403, Tamil Nadu, India

    P. Parthiban

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  1. P. Balamurugan
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Correspondence to P. Balamurugan.

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Balamurugan, P., Anver Basha, K., Jayachandran, J. et al. Simultaneous Chemo/Enantioseparation and Assay of R-(+)-Rabeprazole and Related Impurities in Pharmaceutical Formulations. Chromatographia 78, 1367–1375 (2015). https://doi.org/10.1007/s10337-015-2968-x

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  • DOI: https://doi.org/10.1007/s10337-015-2968-x

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