Scribd Logo
Upload

Welcome to Scribd!

  • 8 views

    Itraconazole Oral Solution

    Uploaded by

    Upendra Reddy
    Itraconazole oral Solutions

    Copyright:

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

    Itraconazole Oral Solution

    Uploaded by

    Upendra Reddy
    8 views3 pages
    Itraconazole oral Solutions

    Copyright

    © © All Rights Reserved

    Available Formats

    PDF, TXT or read online from Scribd

    Did you find this document useful?

    Is this content inappropriate?

    Itraconazole oral Solutions

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    8 views3 pages

    Itraconazole Oral Solution

    Uploaded by

    Upendra Reddy
    Itraconazole oral Solutions

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    You are on page 1of 3

    Itraconazole Oral Solution – BP 2019

    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 the Identification test for Itraconazole Oral Solution by Thin Layer
    Chromatography as published in BP 2019.

    1 Blank
    2 System suitability test 0.2 % w/v itraconazole and 0.2 % w/v fluconazole
    3 0.2 % w/v itraconazole standard solution
    4-5 0.2 % w/v itraconazole oral solution sample solutions

    TLC plate Merck TLC silica gel 60 F254 Plate, 20 cm × 20 cm


    Diluent Dichloromethane
    Mobile Phase 0.015 % w/v of ammonium acetate and 0.0003 % v/v of glacial
    acetic acid in water : 1,4-dioxane : methanol (20:40:40, v/v/v)
    Sample application 5 µL
    Development 100 mm
    Development time 55 minutes
    Drying Dry in air
    Visualisation Developed plates examined under UV light (254 nm)
    Typical chromatogram for solution (3) in the Related Substances test for Itraconazole Oral Solution as
    published in BP 2019.

    8 8

    6 6

    4 4
    mAU

    mAU
    2
    2 1 3 5 2

    0 0

    6
    -2 -2

    4
    0 5 10 15 20 25 30 35 40 45
    Minutes

    Peak ID: 1: Impurity B; 2: Impurity C + D; 3: Impurity E; 4: Itraconazole; 5: Impurity F; 6: Impurity G

    Column : Phenomenex Prodigy ODS (2) (150 mm × 4.6 mm, 5 μm)


    Mobile Phase : 48 volumes of acetonitrile and 52 volumes of 0.01M potassium dihydrogen
    orthophosphate previously adjusted to pH 3.0 with orthophosphoric acid
    Diluent : 0.1 volumes of hydrochloric acid and 50 volumes of mobile phase (solution A)
    Flow Rate : 1.5 mL/min
    Column Temp : 40°C
    Injection Volume : 15 µL
    Detection : UV, 254 nm
    Typical chromatogram for solution (3) in the Assay test for Itraconazole Oral Solution as published in
    BP 2019.

    5 5

    4 4

    3 3

    2
    mAU

    mAU
    2 2
    1
    3
    5

    1 1

    0 0

    -1
    4 -1
    0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34
    Minutes

    Peak ID: 1: Impurity B; 2: Impurity C + D; 3: Impurity E; 4: Itraconazole; 5: Impurity F; 6: Impurity G

    Column : Phenomenex Prodigy ODS (2) (150 mm × 4.6 mm, 5 μm)


    Mobile Phase : 48 volumes of acetonitrile and 52 volumes of 0.01M potassium dihydrogen
    orthophosphate previously adjusted to pH 3.0 with orthophosphoric acid
    Diluent : 0.1 volumes of hydrochloric acid and 50 volumes of mobile phase (solution A)
    Flow Rate : 2.0 mL/min
    Column Temp : 40°C
    Injection Volume : 15 µL
    Detection : UV, 254 nm

    You might also like