Chemical and Biomolecular Engineering

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Development and Validation of RP-HPLC Method for Simultaneous Determination of Amprolium HCl and Ethopabate in Their Combination Drug

Received: 11 January 2017    Accepted: 21 January 2017    Published: 24 February 2017
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Abstract

In this study a simple, rapid, accurate, sensitive and specific reverse phase-high performance liquid chromatographic (RP- HPLC) method was developed and subsequently validated for simultaneous estimation of Amprolium hydrochloride (AMP) and Ethopabate (ETH) in their combination syrup. The separation of the drugs was carried out using a base deactivated silanol (BDS) C18 (250mm x 4.6mm, 5 μm) column, mobile phase consisting of methanol and purified water in the proportion of 60:40 (v/v) containing 0.5% Heptansulfonic acid sodium at pH of 3.7 and flow rate of 1 ml/min. The influence of the instrument operating conditions on the resolution and retention time were tested. The method was linear over a range of 48-480 μg/ml and 3-30 μg/ml with a correlation coefficient (r2) of 0.99996 for AMP and ETH, respectively. The method validations study revealed excellent accuracy, precision, linearity, specificity, limit of detection (LOD) and limit of quantitation (LOQ) of the proposed method according to the international conference harmonization (ICH) guidelines. Moreover, the stability study revealed that the proposed method can also be used for evaluation of purity and degradation of these drugs in their formulations that arisen due to the temperature, humidity and time.

DOI 10.11648/j.cbe.20170201.17
Published in Chemical and Biomolecular Engineering (Volume 2, Issue 1, March 2017)
Page(s) 51-56
Creative Commons

This is an Open Access article, distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium or format, provided the original work is properly cited.

Copyright

Copyright © The Author(s), 2024. Published by Science Publishing Group

Keywords

Amprolium HCl, Ethopabate, Validation, Combination, HPLC

References
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Author Information
  • Department of Chemistry, Faculty of Pure and Applied Science, International University of Africa, Khartoum, Sudan

  • Department of Chemistry, Faculty of Pure and Applied Science, International University of Africa, Khartoum, Sudan

  • Department of Chemistry, Faculty of Pure and Applied Science, International University of Africa, Khartoum, Sudan

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    Mahmoud Mohamed Ali, Mustafa Adballa Algozoly Ahmed, Mahgoub Ibrahim Shinger. (2017). Development and Validation of RP-HPLC Method for Simultaneous Determination of Amprolium HCl and Ethopabate in Their Combination Drug. Chemical and Biomolecular Engineering, 2(1), 51-56. https://doi.org/10.11648/j.cbe.20170201.17

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    Mahmoud Mohamed Ali; Mustafa Adballa Algozoly Ahmed; Mahgoub Ibrahim Shinger. Development and Validation of RP-HPLC Method for Simultaneous Determination of Amprolium HCl and Ethopabate in Their Combination Drug. Chem. Biomol. Eng. 2017, 2(1), 51-56. doi: 10.11648/j.cbe.20170201.17

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    AMA Style

    Mahmoud Mohamed Ali, Mustafa Adballa Algozoly Ahmed, Mahgoub Ibrahim Shinger. Development and Validation of RP-HPLC Method for Simultaneous Determination of Amprolium HCl and Ethopabate in Their Combination Drug. Chem Biomol Eng. 2017;2(1):51-56. doi: 10.11648/j.cbe.20170201.17

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  • @article{10.11648/j.cbe.20170201.17,
      author = {Mahmoud Mohamed Ali and Mustafa Adballa Algozoly Ahmed and Mahgoub Ibrahim Shinger},
      title = {Development and Validation of RP-HPLC Method for Simultaneous Determination of Amprolium HCl and Ethopabate in Their Combination Drug},
      journal = {Chemical and Biomolecular Engineering},
      volume = {2},
      number = {1},
      pages = {51-56},
      doi = {10.11648/j.cbe.20170201.17},
      url = {https://doi.org/10.11648/j.cbe.20170201.17},
      eprint = {https://download.sciencepg.com/pdf/10.11648.j.cbe.20170201.17},
      abstract = {In this study a simple, rapid, accurate, sensitive and specific reverse phase-high performance liquid chromatographic (RP- HPLC) method was developed and subsequently validated for simultaneous estimation of Amprolium hydrochloride (AMP) and Ethopabate (ETH) in their combination syrup. The separation of the drugs was carried out using a base deactivated silanol (BDS) C18 (250mm x 4.6mm, 5 μm) column, mobile phase consisting of methanol and purified water in the proportion of 60:40 (v/v) containing 0.5% Heptansulfonic acid sodium at pH of 3.7 and flow rate of 1 ml/min. The influence of the instrument operating conditions on the resolution and retention time were tested. The method was linear over a range of 48-480 μg/ml and 3-30 μg/ml with a correlation coefficient (r2) of 0.99996 for AMP and ETH, respectively. The method validations study revealed excellent accuracy, precision, linearity, specificity, limit of detection (LOD) and limit of quantitation (LOQ) of the proposed method according to the international conference harmonization (ICH) guidelines. Moreover, the stability study revealed that the proposed method can also be used for evaluation of purity and degradation of these drugs in their formulations that arisen due to the temperature, humidity and time.},
     year = {2017}
    }
    

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  • TY  - JOUR
    T1  - Development and Validation of RP-HPLC Method for Simultaneous Determination of Amprolium HCl and Ethopabate in Their Combination Drug
    AU  - Mahmoud Mohamed Ali
    AU  - Mustafa Adballa Algozoly Ahmed
    AU  - Mahgoub Ibrahim Shinger
    Y1  - 2017/02/24
    PY  - 2017
    N1  - https://doi.org/10.11648/j.cbe.20170201.17
    DO  - 10.11648/j.cbe.20170201.17
    T2  - Chemical and Biomolecular Engineering
    JF  - Chemical and Biomolecular Engineering
    JO  - Chemical and Biomolecular Engineering
    SP  - 51
    EP  - 56
    PB  - Science Publishing Group
    SN  - 2578-8884
    UR  - https://doi.org/10.11648/j.cbe.20170201.17
    AB  - In this study a simple, rapid, accurate, sensitive and specific reverse phase-high performance liquid chromatographic (RP- HPLC) method was developed and subsequently validated for simultaneous estimation of Amprolium hydrochloride (AMP) and Ethopabate (ETH) in their combination syrup. The separation of the drugs was carried out using a base deactivated silanol (BDS) C18 (250mm x 4.6mm, 5 μm) column, mobile phase consisting of methanol and purified water in the proportion of 60:40 (v/v) containing 0.5% Heptansulfonic acid sodium at pH of 3.7 and flow rate of 1 ml/min. The influence of the instrument operating conditions on the resolution and retention time were tested. The method was linear over a range of 48-480 μg/ml and 3-30 μg/ml with a correlation coefficient (r2) of 0.99996 for AMP and ETH, respectively. The method validations study revealed excellent accuracy, precision, linearity, specificity, limit of detection (LOD) and limit of quantitation (LOQ) of the proposed method according to the international conference harmonization (ICH) guidelines. Moreover, the stability study revealed that the proposed method can also be used for evaluation of purity and degradation of these drugs in their formulations that arisen due to the temperature, humidity and time.
    VL  - 2
    IS  - 1
    ER  - 

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