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

Mahmoud Mohamed Ali; Mustafa Adballa Algozoly Ahmed; Mahgoub Ibrahim Shinger

doi:doi:10.11648/j.cbe.20170201.17

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

Mahmoud Mohamed Ali, Mustafa Adballa Algozoly Ahmed, Mahgoub Ibrahim Shinger

Published in Chemical and Biomolecular Engineering (Volume 2, Issue 1)

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.

Published in	Chemical and Biomolecular Engineering (Volume 2, Issue 1)
DOI	10.11648/j.cbe.20170201.17
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), 2017. Published by Science Publishing Group

Keywords

Amprolium HCl, Ethopabate, Validation, Combination, HPLC

References

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APA Style

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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ACS 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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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://article.sciencepublishinggroup.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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Author Information

Mahmoud Mohamed Ali

Department of Chemistry, Faculty of Pure and Applied Science, International University of Africa, Khartoum, Sudan
Mustafa Adballa Algozoly Ahmed

Department of Chemistry, Faculty of Pure and Applied Science, International University of Africa, Khartoum, Sudan
Mahgoub Ibrahim Shinger

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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ACS 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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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://article.sciencepublishinggroup.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}
}

Copy | Download

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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