Scribd Logo
Upload

Welcome to Scribd!

  • 11 views

    Rivaroxaban USP - Method Evaluation Report

    Uploaded by

    Sesilia Dyah Novitriani
    This document evaluates the USP pharmacopeial method for analyzing the enantiomeric purity of the drug substance Rivaroxaban. The method uses a chiral chromatography column and detects two peaks corresponding to the R-enantiomer and Rivaroxaban. The system suitability solution was tested and found to have a resolution of 2.65 and tailing factors within specified limits, although the retention times were different than reported in the monograph. The test solution also showed a single peak for Rivaroxaban within the expected retention time.

    Copyright:

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

    Rivaroxaban USP - Method Evaluation Report

    Uploaded by

    Sesilia Dyah Novitriani
    11 views4 pages
    This document evaluates the USP pharmacopeial method for analyzing the enantiomeric purity of the drug substance Rivaroxaban. The method uses a chiral chromatography column and detects two peaks corresponding to the R-enantiomer and Rivaroxaban. The system suitability solution was tested and found to have a resolution of 2.65 and tailing factors within specified limits, although the retention times were different than reported in the monograph. The test solution also showed a single peak for Rivaroxaban within the expected retention time.

    Original Title

    Rivaroxaban USP - method evaluation report

    Copyright

    © © All Rights Reserved

    Available Formats

    PDF, TXT or read online from Scribd

    Did you find this document useful?

    Is this content inappropriate?

    This document evaluates the USP pharmacopeial method for analyzing the enantiomeric purity of the drug substance Rivaroxaban. The method uses a chiral chromatography column and detects two peaks corresponding to the R-enantiomer and Rivaroxaban. The system suitability solution was tested and found to have a resolution of 2.65 and tailing factors within specified limits, although the retention times were different than reported in the monograph. The test solution also showed a single peak for Rivaroxaban within the expected retention time.

    Copyright:

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

    Rivaroxaban USP - Method Evaluation Report

    Uploaded by

    Sesilia Dyah Novitriani
    This document evaluates the USP pharmacopeial method for analyzing the enantiomeric purity of the drug substance Rivaroxaban. The method uses a chiral chromatography column and detects two peaks corresponding to the R-enantiomer and Rivaroxaban. The system suitability solution was tested and found to have a resolution of 2.65 and tailing factors within specified limits, although the retention times were different than reported in the monograph. The test solution also showed a single peak for Rivaroxaban within the expected retention time.

    Copyright:

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

    GGDAC – PHARMACOPEIAL METHOD EVALUATION

    PRODUCT: Structure:

    RIVAROXABAN

    U.S. PHARMACOPEIA METHOD: Enantiomeric Purity:


    [Reference: USP PF Online]

    Chromatographic conditions:

    Column : Chiralcel OD 250 mm * 2.0 mm, 10 μm (L40)

    Mobile phase : n-Heptane: Ethanol (70:30; v/v)

    Flow rate : 0.2 mL/min

    Injection volume : 3.0 µL

    Column temperature : 50°C

    UV detection : 250 nm

    Run time : NLT 1.5 times the retention time of Rivaroxaban

    Note:

    • Used Chiracel OD, 250 mm * 2.1 mm, 10 microns column)

    • The column temperature as per the method is 10°C more that the recommended column maximum
    temperature of 40°C.

    Solution preparations:

    Diluent: Acetonitrile: Ethanol (50:50; v/v)

    System suitability solution:

    System suitability solution containing 0.4 mg/mL of USP Rivaroxaban RS and 0.004 mg/mL of
    USP Rivaroxaban R-Enantiomer was prepared by adding Acetonitrile up to 50% of volumetric
    flask sonicated to dissolve and diluted with ethanol to the volume.

    Sample solution:

    Sample solution containing 0.4 mg/mL of Rivaroxaban was prepared by adding Acetonitrile up
    to 50% of volumetric flask sonicated to dissolve and diluted with ethanol to the volume.

    Note: Sonication of 10-15 minutes is required to dissolve the sample solution.


    Page 1 of 4
    GGDAC – PHARMACOPEIAL METHOD EVALUATION
    PRODUCT: Structure:

    RIVAROXABAN

    System suitability requirements:

    Resolution:

    NLT 1.5 between Rivaroxaban R-Enantiomer and Rivaroxaban.

    Tailing factor:

    NMT 1.5 for Rivaroxaban.

    System suitability solution results:

    Peak Retention Time Relative Resolution Tailing factor


    (RT) Retention Time (Rs)
    (RRT)

    R-Enantiomer 23.32 min. 0.81 -- 1.11

    Rivaroxaban 28.72 min 1.0 2.65 1.27

    Note: Observed retention times different of 4.0 minutes and 6.0 minutes for R-enantiomer and
    Rivaroxaban peaks respectively against the retention time mentioned in the monograph.

    Page 2 of 4
    GGDAC – PHARMACOPEIAL METHOD EVALUATION
    PRODUCT: Structure:

    RIVAROXABAN

    Typical Chromatograms:

    Blank:
    DAD1A, Sig=250,4Ref=off (E:\CHEMSTATION\1\DATA\10_19199_RIVAROXABAN_USP\10_11190005.D)
    mAU

    60

    50

    40

    30

    20

    10

    5 10 15 20 25 30 35 40 45 min

    System Suitability solution:


    DAD1A, Sig=250,4Ref=off (E:\CHEMSTATION\1\DATA\10_19199_RIVAROXABAN_USP\10_11190008.D)
    28.720 - Rivaroxaban

    mAU

    40

    30

    20
    23.319 - R-Enantiomer

    10

    5 10 15 20 25 30 35 40 45 min

    Page 3 of 4
    GGDAC – PHARMACOPEIAL METHOD EVALUATION
    PRODUCT: Structure:

    RIVAROXABAN

    Test solution:

    DAD1 A, Sig=250,4 Ref=off (E:\CHEMSTATION\1\DATA\10_19199_RIVAROXABAN_USP\10_11190009.D)

    28.710 - Rivaroxaban
    mAU

    40

    30

    20

    10

    5 10 15 20 25 30 35 40 45 min

    Page 4 of 4

    You might also like

    pFad - Phonifier reborn

    Pfad - The Proxy pFad of © 2024 Garber Painting. All rights reserved.

    Note: This service is not intended for secure transactions such as banking, social media, email, or purchasing. Use at your own risk. We assume no liability whatsoever for broken pages.


    Alternative Proxies:

    Alternative Proxy

    pFad Proxy

    pFad v3 Proxy

    pFad v4 Proxy