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    Angie Flores
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    This document describes the development of a simple HPLC/ELSD method to determine the amount of Polysorbate 80 in a pharmaceutical formulation. It presents standard curves and chromatograms from studies evaluating the method's specificity, precision, and accuracy at quantifying Polysorbate 80 at levels from 40-140% when tested in a sample of an ophthalmic emulsion formulation.

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    This document describes the development of a simple HPLC/ELSD method to determine the amount of Polysorbate 80 in a pharmaceutical formulation. It presents standard curves and chromatograms from studies evaluating the method's specificity, precision, and accuracy at quantifying Polysorbate 80 at levels from 40-140% when tested in a sample of an ophthalmic emulsion formulation.

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    © All Rights Reserved
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    10 views4 pages

    Supporting Information

    Uploaded by

    Angie Flores
    This document describes the development of a simple HPLC/ELSD method to determine the amount of Polysorbate 80 in a pharmaceutical formulation. It presents standard curves and chromatograms from studies evaluating the method's specificity, precision, and accuracy at quantifying Polysorbate 80 at levels from 40-140% when tested in a sample of an ophthalmic emulsion formulation.

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    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
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    of 4

    Supporting Information

    Development of a simple high performance liquid chromatography (HPLC) /evaporative


    light scattering detector (ELSD) method to determine Polysorbate 80 in a pharmaceutical
    formulation

    Bikash Mondal*, Mahesh Kote, Chandrakant Lunagariya, Milan Patel

    Address: Research and Development, Akorn Pharmaceuticals, 50 Lake View Parkway,


    Suite#112, Vernon Hills, Illinois, 60061, United States of America.

    *Corresponding Author, Email: Bikash.Mondal@akorn.com

    Page 1 of 4
    Fig S1. Representative overlay chromatogram of Standard Solution of a) Polysorbate 80, b)
    API c) Cabomer Copolymer Type A (Pemulen TR-2), d) Glycerin, and e) Castor Oil to show
    the method specificity

    Fig S2. Standard curve used for quantification of Polysorbate 80

    Page 2 of 4
    Fig S3. Representative chromatogram from precision study

    Fig S4. Representative chromatogram from accuracy study at 40% level

    Fig S5. Representative chromatogram from accuracy study at 100% level

    Page 3 of 4
    Fig S6. Representative chromatogram for accuracy study at 140% level

    Fig S7. Representative chromatogram from the pharmaceutical formulation (an


    ophthalmic emulsion)

    Page 4 of 4

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