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    Simvastatin Oral Suspension BP 2015

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    Angga M Rahman
    This document provides chromatograms as guidance for interpreting and applying the British Pharmacopoeia monograph for Simvastatin Oral Suspension. It describes the column, mobile phase gradient, diluent, flow rate, temperature, injection volume, and detection used in the related substances test and assay. The typical chromatograms show peaks for Simvastatin and various impurities.

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    Download as PDF, TXT or read online from Scribd

    Simvastatin Oral Suspension BP 2015

    Uploaded by

    Angga M Rahman
    31 views2 pages
    This document provides chromatograms as guidance for interpreting and applying the British Pharmacopoeia monograph for Simvastatin Oral Suspension. It describes the column, mobile phase gradient, diluent, flow rate, temperature, injection volume, and detection used in the related substances test and assay. The typical chromatograms show peaks for Simvastatin and various impurities.

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    Simvastatin Oral Suspension BP 2015

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    This document provides chromatograms as guidance for interpreting and applying the British Pharmacopoeia monograph for Simvastatin Oral Suspension. It describes the column, mobile phase gradient, diluent, flow rate, temperature, injection volume, and detection used in the related substances test and assay. The typical chromatograms show peaks for Simvastatin and various impurities.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    31 views2 pages

    Simvastatin Oral Suspension BP 2015

    Uploaded by

    Angga M Rahman
    This document provides chromatograms as guidance for interpreting and applying the British Pharmacopoeia monograph for Simvastatin Oral Suspension. It describes the column, mobile phase gradient, diluent, flow rate, temperature, injection volume, and detection used in the related substances test and assay. The typical chromatograms show peaks for Simvastatin and various impurities.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 2

    Simvastatin Oral Suspension BP 2015

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

    Column : Phenomenex Gemini C18 Cartridge (30 mm x 4.6 mm, 5m)


    Method Ref. : Related substances method for the Simvastatin Oral Suspension monograph
    from BP 2015
    Mobile Phase A : A mixture of 50 volumes of acetonitrile and 50 volumes of a 0.1% v/v solution
    of orthophosphoric acid.
    Mobile Phase B : 0.1% v/v solution of orthophosphoric acid in acetonitrile.
    Gradient : Time (min) Mobile Phase A (% v/v) Mobile Phase B (% v/v)
    0-4.5 100 0
    4.5-4.6 100-95 0-5
    4.6-8.0 95-25 5-75
    8.0-11.5 25 75
    11.5-12.5 25-100 75-0
    12.5-17.5 100 0
    Diluent : A mixture of 45 volumes of a 0.14% w/v solution of potassium dihydrogen
    phosphate, adjusted to pH 4.0 with orthophosphoric acid, and 55 volumes of
    acetonitrile.
    Flow Rate : 3.0 mL/min
    Column Temp : 30C
    Injection Volume : 75 L
    Detection : 238 nm

    Typical chromatogram for solution (5) in the Related substances test for Simvastatin Oral Suspension
    as published in BP 2015.

    70 70

    60 60

    50 50

    40 40
    mAU

    mAU

    30 30

    20 20

    10 6 10
    2
    1 5
    3
    0 0

    -10 -10

    4
    1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18
    Minutes

    Peak ID: 1: Impurity A; 2: Impurity E+F; 3: Impurity G; 4: Simvastatin; 5: Impurity B+C; 6: Impurity D
    Typical chromatogram for solution (4) in the Related substances test and solution (3) in the Assay for
    Simvastatin Oral Suspension as published in BP 2015.

    225 225

    1
    200 200

    175 175

    150
    2 150

    125 125
    mAU

    mAU
    100 100

    75 75

    50 50

    25 25

    0 0

    -25 -25
    0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18
    Minutes

    Peak ID: 1: Impurity E; 2: Simvastatin

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