Development and Validation of RP-HPLC Method for Simultaneous Determination of Amprolium HCl and Ethopabate in Their Combination Drug
Chemical and Biomolecular Engineering
Volume 2, Issue 1, March 2017, Pages: 51-56
Received: Jan. 11, 2017; Accepted: Jan. 21, 2017; Published: Feb. 24, 2017
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Authors
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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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.
Keywords
Amprolium HCl, Ethopabate, Validation, Combination, HPLC
To cite this article
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, Chemical and Biomolecular Engineering. Vol. 2, No. 1, 2017, pp. 51-56. doi: 10.11648/j.cbe.20170201.17
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Copyright © 2017 Authors retain the copyright of this article.
This article is an open access article distributed under the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/) which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
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