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    Azithromycin Tablets PDF

    Uploaded by

    sonika sharma
    The document provides typical chromatograms for the related substances test and assay test for azithromycin tablets as published in the British Pharmacopoeia 2018. The chromatograms show the separation and detection of azithromycin and various impurities using different HPLC columns, mobile phase gradients, and detection methods. Key details about the analytical methods and identified peaks are also presented.

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

    Azithromycin Tablets PDF

    Uploaded by

    sonika sharma
    29 views4 pages
    The document provides typical chromatograms for the related substances test and assay test for azithromycin tablets as published in the British Pharmacopoeia 2018. The chromatograms show the separation and detection of azithromycin and various impurities using different HPLC columns, mobile phase gradients, and detection methods. Key details about the analytical methods and identified peaks are also presented.

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    Azithromycin-Tablets.pdf

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    The document provides typical chromatograms for the related substances test and assay test for azithromycin tablets as published in the British Pharmacopoeia 2018. The chromatograms show the separation and detection of azithromycin and various impurities using different HPLC columns, mobile phase gradients, and detection methods. Key details about the analytical methods and identified peaks are also presented.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    29 views4 pages

    Azithromycin Tablets PDF

    Uploaded by

    sonika sharma
    The document provides typical chromatograms for the related substances test and assay test for azithromycin tablets as published in the British Pharmacopoeia 2018. The chromatograms show the separation and detection of azithromycin and various impurities using different HPLC columns, mobile phase gradients, and detection methods. Key details about the analytical methods and identified peaks are also presented.

    Copyright:

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

    Azithromycin Tablets – BP 2018

    These chromatograms are provided for information only as an aid to analysts and are intended as
    guidance for the interpretation and application of BP monographs.

    Typical chromatogram for solution (3) in the Related Substances test for Azithromycin Tablets as
    published in BP 2018.

    35

    30

    25

    20

    3
    m AU

    15

    10
    1

    2
    5

    -5
    0 5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 85 90
    Minutes

    Peak ID: 1: Impurity F, 2: Impurity J, 3: Impurity H


    Typical chromatogram for solution (4) in the Related Substances test for Azithromycin Tablets as
    published in BP 2018.

    30.0 30.0

    27.5 27.5

    25.0 25.0

    22.5 22.5

    20.0 20.0

    17.5 17.5

    15.0 14 15.0
    mAU

    mAU
    12.5 12.5

    10.0 10 13 10.0

    2 12
    1
    7.5
    4 8 7.5

    5 9
    5.0
    6 5.0
    3

    2.5 7 2.5

    0.0 0.0

    -2.5 -2.5

    11
    -5.0 -5.0
    0 5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 85 90
    Minutes

    Peak ID: 1: Impurity L; 2: Impurity M; 3: Imurity E; 4: Impurity F; 5: Impurity J; 6: Impurity I; 7: Impurity


    N; 8: Impurity A; 9: Impurity P; 10: Azithromycin; 11: Impurity O; 12: Impurity G; 13: Impurity B
    Column : Waters, C18 Xterra MS (250 mm x 4.6 mm, 5 µm)
    Method Ref. : Related substances for the Azithromycin Tablets monograph from BP 2018
    Mobile Phase A : 0.180 % w/v solution of anhydrous disodium hydrogen orthophosphate adjusted
    to pH 8.9 with dilute orthophosphoric acid or with dilute sodium hydroxide
    solution.

    Mobile phase B : Methanol: acetonitrile (25:75 v/v)


    Gradient: :
    Time Mobile phase A Mobile phase B
    (minutes) (% v/v) (% v/v)
    0 – 30 50 → 45 50 → 55
    30 – 35 45 → 40 55 → 60
    35 – 80 40 → 25 60 → 75
    80 – 81 25 → 50 75 → 50
    81 – 93 50 50

    Diluent : Solvent A (35 volumes of 0.173 % w/v solution of ammonium dihydrogen


    orthophosphate adjusted to pH 10.0 with ammonia, 35 volumes of methanol and 30 volumes of
    acetonitrile).

    Flow Rate : 1.0 mL/min


    Column Temp : 60°C
    Injection Volume : 50 µL
    Detection : UV, 210 nm
    Typical chromatogram for solution (3) in the Assay test for Azithromycin Tablets as published in BP
    2018.

    30.0

    27.5
    2

    25.0

    22.5
    1
    20.0

    17.5

    15.0

    12.5
    mAU

    10.0

    7.5

    5.0

    2.5

    0.0

    -2.5

    -5.0

    -7.5

    -10.0

    0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15
    Minutes

    Peak ID: 1: Impurity A; 2: Azithromycin

    Column : Shodex, Asahipak ODP-50 (250 mm x 4.6 mm, 5 µm)


    Method Ref. : Assay for the Azithromycin Tablets monograph from BP 2018
    Mobile Phase : Acetonitrile: buffer (60:40, v/v)
    Diluent : Solvent A (40 volumes of 0.67 % w/v solution of dipotassium hydrogen
    orthophosphate adjusted to pH 8.0 with orthophosphoric acid and 60 volumes of
    acetonitrile)
    Flow Rate : 1.0 mL/min
    Column Temp : 40°C
    Injection Volume : 10 µL
    Detection : UV, 210 nm

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