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    Fluconazole Tablets USP Monograph

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    Fluconazole Tablets USP Monograph

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    Fluconazole Tablets USP Monograph

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    Fluconazole Tablets USP Monograph

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    Fluconazole Tablets USP Monograph

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

    Fluconazole Tablets USP Monograph

    Uploaded by

    Piyush
    Fluconazole Tablets USP Monograph

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
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    © 2019 USPC Official 5/1/16 - 7/31/16 USP Monographs: Fluconazole Tablets Page 1 of 4

    Fluconazole Tablets

    DEFINITION
    Fluconazole Tablets contain NLT 90.0% and NMT 110.0% of the labeled amount of
    fluconazole (C13H12F2N6O).

    IDENTIFICATION
    • The retention time of the major peak of the Sample solution corresponds to that of the
    Standard solution, as obtained in the Assay.

    ASSAY
    • PROCEDURE
    Buffer: 0.01 M anhydrous sodium acetate solution. Adjust with glacial acetic acid to a pH of
    5.0.
    Mobile phase: Methanol, acetonitrile, and Buffer (20:10:70)
    Standard stock solution: 1.0 mg/mL of USP Fluconazole RS dissolved in water, and
    diluted with Mobile phase to volume. Sonicate the solution, if necessary. [NOTE— The target
    ratio is about 5% water to 95% Mobile phase. ]
    Standard solution: 0.2 mg/mL of USP Fluconazole RS in Mobile phase prepared from the
    Standard stock solution
    Sample solution: Weigh NLT 5 Tablets, and disperse in a suitable quantity of water.
    Sonicate the solution, if necessary. Add a sufficient quantity of Mobile phase, sonicate for 5
    min, and shake for 30 min. Dilute with Mobile phase to volume to obtain a concentration
    between about 1 and 4 mg/mL, and mix. [NOTE— The target ratio is about 5% water to
    95% Mobile phase. ] Centrifuge a suitable portion of the mixture. Filter and quantitatively
    dilute a portion of the supernatant with Mobile phase to obtain a solution of about 0.2
    mg/mL of fluconazole .
    Chromatographic system
    (See Chromatography 〈621〉 , System Suitability.)
    Mode: LC
    Detector: UV 261 nm
    Column: 3.9-mm × 150-mm; 4-µm packing L1
    Flow rate: 1 mL/min
    Injection size: 20 µL
    System suitability
    Sample: Standard solution
    Suitability requirements
    Column efficiency: NLT 1100 theoretical plates
    Tailing factor: NMT 3.0
    Relative standard deviation: NMT 2.0%
    Analysis

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    Samples: Standard solution and Sample solution


    Calculate the percentage of the labeled amount of fluconazole (C13H12F2N6O) in the portion
    of Tablets taken:
    Result = ( r U /r S )×(C S /C U ) × 100

    r U = peak response from the Sample solution


    r S = peak response from the Standard solution
    C S = concentration of USP Fluconazole RS in the Standard solution (mg/mL)
    C U = nominal concentration of fluconazole in the Sample solution (mg/mL)

    Acceptance criteria: 90.0%–110.0%

    PERFORMANCE TESTS
    • DISSOLUTION 〈711〉
    Test 1
    Medium: Water; 500 mL (900 mL for Tablets labeled to contain more than 100 mg)
    Apparatus 2: 50 rpm
    Time: 45 min
    Buffer, Mobile phase, and System suitability: Proceed as directed in the Assay.
    Standard solution: 2 mg/mL of USP Fluconazole RS in Medium. Sonicate the solution to
    facilitate dissolution, if necessary. Quantitatively dilute a portion of this solution with
    Medium to obtain a final concentration similar to the one expected in the Sample solution.
    Sample solution: Pass a portion of the solution under test through a suitable filter of
    0.45-µm pore size.
    Chromatographic system and System suitability: Proceed as directed in the Assay,
    making any necessary modifications.
    Analysis
    Samples: Standard solution and Sample solution
    Calculate the percentage of the labeled amount of fluconazole (C13H12F2N6O) dissolved:
    Result = ( r U /r S )×(C S /L) × V × 100

    r U = peak response from the Sample solution


    r S = peak response from the Standard solution
    C S = concentration of USP Fluconazole RS in the Standard solution (mg/mL)
    L = label claim (mg/Tablet)
    V = volume of Medium, 500 or 900 mL
    Tolerances: NLT 75% (Q) of the labeled amount of C13H12F2N6O is dissolved.

    Test 2: If the product complies with this test, the labeling indicates that it meets Dissolution
    Test 2.
    Medium: Water; 900 mL (for all Tablet strengths)
    Apparatus 2: 50 rpm

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    Time: 45 min
    Mobile phase: Water and acetonitrile (4:1)
    Standard stock solution: 1.1 mg/mL of USP Fluconazole RS in methanol
    Standard solution: Dilute the Standard stock solution with Medium to obtain a final
    concentration of (L/900) mg/mL, where L is the Tablet label claim in mg.
    Sample solution: Pass a portion of the solution under test through a suitable filter.
    Chromatographic system
    (See Chromatography 〈621〉 , System Suitability.)
    Mode: LC
    Detector: UV 260 nm
    Column: 4.6-mm × 15-cm; 5-µm packing L1
    Column temperature: 40°
    Flow rate: 1.5 mL/min
    Injection size: 50 µL
    System suitability
    Sample: Standard solution
    Suitability requirements
    Column efficiency: NLT 1000 theoretical plates
    Tailing factor: NMT 1.5
    Relative standard deviation: NMT 2.0%
    Calculate the percentage of the labeled amount of fluconazole (C13H12F2N6O) dissolved:
    Result = ( r U /r S )×(C S /L) × V × 100

    r U = peak response from the Sample solution


    r S = peak response from the Standard solution
    C S = concentration of the Standard solution (mg/mL)
    L = label claim (mg/Tablet)
    V = volume of Medium, 900 mL
    Tolerances: NLT 75% (Q) of the labeled amount of fluconazole is dissolved.
    • UNIFORMITY OF DOSAGE UNITS 〈905〉 : Meet the requirements

    ADDITIONAL REQUIREMENTS
    • PACKAGING AND STORAGE: Preserve in well-closed containers. Store at controlled room
    temperature.
    • LABELING: When more than one Dissolution test is given, the labeling states the Dissolution
    test used only if Test 1 is not used.
    • USP REFERENCE STANDARDS 〈11〉
    USP Fluconazole RS

    Auxiliary Information— Please check for your question in the FAQs before contacting USP.

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    Topic/Question Contact Expert Committee

    Monograph Shankari Shivaprasad, (CHM12015) Chemical Medicines


    Ph.D. Monographs 1
    Scientific Liaison
    (301) 230-7426

    〈711〉 Margareth R.C. (GCDF2015) General Chapters-


    Marques, Ph.D. Dosage Forms 2015
    Principal Scientific
    Liaison
    (301) 816-8106

    Reference RS Technical Services


    Standards 1-301-816-8129
    [email protected]
    USP39–NF34 Page 3934
    Pharmacopeial Forum: Volume No. 34(4) Page 932

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