Development and Validation for HPLC Method of Assay of Lvermectin and Clorsulon in Combined Pharmaceutical Dosage Form

Mahmoud Mohamed Ali; Elfatih Elbashir; Mohamed N. Abdalaziz

doi:doi:10.11648/j.ijhnm.20170306.11

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Development and Validation for HPLC Method of Assay of Lvermectin and Clorsulon in Combined Pharmaceutical Dosage Form

Mahmoud Mohamed Ali, Elfatih Elbashir, Mohamed N. Abdalaziz

Published in International Journal of Homeopathy & Natural Medicines (Volume 3, Issue 6)

Received: 15 September 2017 Accepted: 6 November 2017 Published: 16 January 2018

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Abstract

Stability indicating-HPLC method has been developed for simultaneous estimation of Ivermectin and Clorsulon in their combined dosage form. For RP-HPLC method, all the standard and sample solutions were prepared in methanol. A RP-HPLC method has been developed and subsequently validated for simultaneous estimation of Ivermectin and Clorsulon in their combination product. The proposed RP-HPLC method utilizes a Thermo BDS C-18 (15cm x 4.6mm, 5 μm) column, mobile phase consisting of acetonitrile, methanol and purified water in the proportion of 60: 30:10 (v/v/v), and UV detection at 245 nm. The described method was linear over a range of 10-40μg/ml with a correlation coefficient (r²) of 0.9998 for Ivermectin and a range of 100-400μg/ml with a correlation coefficient (r²) of 0.9998 for Clorsulon. Validations of the proposed method were carried out for its accuracy, precision, linearity and range, specificity, LOD and LOQ according to ICH guidelines. A stability-indicating study was also carried out and indicated that this method can also be used for purity and degradation evaluation of these formulations that occurred due to temperature, humidity and time. the method has been successfully applied for the analysis of drugs in formulation.

Published in	International Journal of Homeopathy & Natural Medicines (Volume 3, Issue 6)
DOI	10.11648/j.ijhnm.20170306.11
Page(s)	45-55
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), 2018. Published by Science Publishing Group

Keywords

Ivermectin, Clorsulon, RP-HPLC, Limit of Detection, Limit of Quantitation

References

[1]	Oltean E. G. and Nica A (2011), Development and Validation of a RP- HPLC Method for the. Quantitation Studies of Ivermectin in Solutions Dosage Forms, Veterinary Drugs, 5 (2), 68–70.
[2]	Prieto J. G. and Merino G, 2003, Improved LC Method to Determine Ivermectin in Plasma, J. Pharma. Bio. Ana.; 31, 639–645.
[3]	International Bulletin of Drug Research., 4 (6): 140-147, 2014 [147].
[4]	Oka A H. and Ikai Y, Separation of Ivermectin Components by High-Speed Counter-Current Chromatography. chroma. A, 1996; 723, 61-68.
[5]	Reuvers Th. and Dlaz R, (1993), Rapid Screening Method for Ivermectin Residue Detection in Cattle Muscle and Liver by Liquid Chromatography with UV Detection, Ana. Chemica. Acta, 275, 353-358.
[6]	Harod S. S. and Manocha N, (2012) Development and validation of analytical method for fluconazole and ivermectin in tablet formulation by using RP-HPLC. IRJ. of pharmacy; 3,257-261.
[7]	The United States Pharmacopoeia, 24th revision, pp. 17-39, U. S. Pharmacopeial Convention, Rockville, MD, 2007.
[8]	British Pharmacopoeia CD 2013, version 17, The Stationery O_ce Ltd., Norwich, 2013.
[9]	European Pharmacopoeia 1997, third edition, pp. 748-749, Convention on the Elaboration of a European.
[10]	Ivermectin, Written by P. Junquera Last Updated on December 20, 2014, available at PARASITIPEDIA.net.
[11]	European public MRL assessment report (EPMAR) for Clorsulon (extrapolation to milk) EMA/CVMP/813332/2011. Website www.ema.europa.eu.
[12]	ICH guideline Q2 (R1). Validation of analytical procedures: textsand methodology. Geneva: 1996.
[13]	ICH, Q2B (1993). Validation of Analytical Procedure: Methodology, International Conference on Harmonization, Geneva, March 1996. Reviewer Guidance, Validation of Chromatographic Methods, Center for Drug Evaluation and Research, Food and Drug Administration, USA, 1994.

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APA Style

Mahmoud Mohamed Ali, Elfatih Elbashir, Mohamed N. Abdalaziz. (2018). Development and Validation for HPLC Method of Assay of Lvermectin and Clorsulon in Combined Pharmaceutical Dosage Form. International Journal of Homeopathy & Natural Medicines, 3(6), 45-55. https://doi.org/10.11648/j.ijhnm.20170306.11

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ACS Style

Mahmoud Mohamed Ali; Elfatih Elbashir; Mohamed N. Abdalaziz. Development and Validation for HPLC Method of Assay of Lvermectin and Clorsulon in Combined Pharmaceutical Dosage Form. Int. J. Homeopathy Nat. Med. 2018, 3(6), 45-55. doi: 10.11648/j.ijhnm.20170306.11

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AMA Style

Mahmoud Mohamed Ali, Elfatih Elbashir, Mohamed N. Abdalaziz. Development and Validation for HPLC Method of Assay of Lvermectin and Clorsulon in Combined Pharmaceutical Dosage Form. Int J Homeopathy Nat Med. 2018;3(6):45-55. doi: 10.11648/j.ijhnm.20170306.11

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@article{10.11648/j.ijhnm.20170306.11,
  author = {Mahmoud Mohamed Ali and Elfatih Elbashir and Mohamed N. Abdalaziz},
  title = {Development and Validation for HPLC Method of Assay of Lvermectin and Clorsulon in Combined Pharmaceutical Dosage Form},
  journal = {International Journal of Homeopathy & Natural Medicines},
  volume = {3},
  number = {6},
  pages = {45-55},
  doi = {10.11648/j.ijhnm.20170306.11},
  url = {https://doi.org/10.11648/j.ijhnm.20170306.11},
  eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.ijhnm.20170306.11},
  abstract = {Stability indicating-HPLC method has been developed for simultaneous estimation of Ivermectin and Clorsulon in their combined dosage form. For RP-HPLC method, all the standard and sample solutions were prepared in methanol. A RP-HPLC method has been developed and subsequently validated for simultaneous estimation of Ivermectin and Clorsulon in their combination product. The proposed RP-HPLC method utilizes a Thermo BDS C-18 (15cm x 4.6mm, 5 μm) column, mobile phase consisting of acetonitrile, methanol and purified water in the proportion of 60: 30:10 (v/v/v), and UV detection at 245 nm. The described method was linear over a range of 10-40μg/ml with a correlation coefficient (r2) of 0.9998 for Ivermectin and a range of 100-400μg/ml with a correlation coefficient (r2) of 0.9998 for Clorsulon. Validations of the proposed method were carried out for its accuracy, precision, linearity and range, specificity, LOD and LOQ according to ICH guidelines. A stability-indicating study was also carried out and indicated that this method can also be used for purity and degradation evaluation of these formulations that occurred due to temperature, humidity and time. the method has been successfully applied for the analysis of drugs in formulation.},
 year = {2018}
}

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TY  - JOUR
T1  - Development and Validation for HPLC Method of Assay of Lvermectin and Clorsulon in Combined Pharmaceutical Dosage Form
AU  - Mahmoud Mohamed Ali
AU  - Elfatih Elbashir
AU  - Mohamed N. Abdalaziz
Y1  - 2018/01/16
PY  - 2018
N1  - https://doi.org/10.11648/j.ijhnm.20170306.11
DO  - 10.11648/j.ijhnm.20170306.11
T2  - International Journal of Homeopathy & Natural Medicines
JF  - International Journal of Homeopathy & Natural Medicines
JO  - International Journal of Homeopathy & Natural Medicines
SP  - 45
EP  - 55
PB  - Science Publishing Group
SN  - 2472-2316
UR  - https://doi.org/10.11648/j.ijhnm.20170306.11
AB  - Stability indicating-HPLC method has been developed for simultaneous estimation of Ivermectin and Clorsulon in their combined dosage form. For RP-HPLC method, all the standard and sample solutions were prepared in methanol. A RP-HPLC method has been developed and subsequently validated for simultaneous estimation of Ivermectin and Clorsulon in their combination product. The proposed RP-HPLC method utilizes a Thermo BDS C-18 (15cm x 4.6mm, 5 μm) column, mobile phase consisting of acetonitrile, methanol and purified water in the proportion of 60: 30:10 (v/v/v), and UV detection at 245 nm. The described method was linear over a range of 10-40μg/ml with a correlation coefficient (r2) of 0.9998 for Ivermectin and a range of 100-400μg/ml with a correlation coefficient (r2) of 0.9998 for Clorsulon. Validations of the proposed method were carried out for its accuracy, precision, linearity and range, specificity, LOD and LOQ according to ICH guidelines. A stability-indicating study was also carried out and indicated that this method can also be used for purity and degradation evaluation of these formulations that occurred due to temperature, humidity and time. the method has been successfully applied for the analysis of drugs in formulation.
VL  - 3
IS  - 6
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
Elfatih Elbashir

Department of Chemistry, Faculty of Pure and Applied Science, International University of Africa., Khartoum, Sudan
Mohamed N. Abdalaziz

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

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APA Style

Mahmoud Mohamed Ali, Elfatih Elbashir, Mohamed N. Abdalaziz. (2018). Development and Validation for HPLC Method of Assay of Lvermectin and Clorsulon in Combined Pharmaceutical Dosage Form. International Journal of Homeopathy & Natural Medicines, 3(6), 45-55. https://doi.org/10.11648/j.ijhnm.20170306.11

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ACS Style

Mahmoud Mohamed Ali; Elfatih Elbashir; Mohamed N. Abdalaziz. Development and Validation for HPLC Method of Assay of Lvermectin and Clorsulon in Combined Pharmaceutical Dosage Form. Int. J. Homeopathy Nat. Med. 2018, 3(6), 45-55. doi: 10.11648/j.ijhnm.20170306.11

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AMA Style

Mahmoud Mohamed Ali, Elfatih Elbashir, Mohamed N. Abdalaziz. Development and Validation for HPLC Method of Assay of Lvermectin and Clorsulon in Combined Pharmaceutical Dosage Form. Int J Homeopathy Nat Med. 2018;3(6):45-55. doi: 10.11648/j.ijhnm.20170306.11

Copy | Download

@article{10.11648/j.ijhnm.20170306.11,
  author = {Mahmoud Mohamed Ali and Elfatih Elbashir and Mohamed N. Abdalaziz},
  title = {Development and Validation for HPLC Method of Assay of Lvermectin and Clorsulon in Combined Pharmaceutical Dosage Form},
  journal = {International Journal of Homeopathy & Natural Medicines},
  volume = {3},
  number = {6},
  pages = {45-55},
  doi = {10.11648/j.ijhnm.20170306.11},
  url = {https://doi.org/10.11648/j.ijhnm.20170306.11},
  eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.ijhnm.20170306.11},
  abstract = {Stability indicating-HPLC method has been developed for simultaneous estimation of Ivermectin and Clorsulon in their combined dosage form. For RP-HPLC method, all the standard and sample solutions were prepared in methanol. A RP-HPLC method has been developed and subsequently validated for simultaneous estimation of Ivermectin and Clorsulon in their combination product. The proposed RP-HPLC method utilizes a Thermo BDS C-18 (15cm x 4.6mm, 5 μm) column, mobile phase consisting of acetonitrile, methanol and purified water in the proportion of 60: 30:10 (v/v/v), and UV detection at 245 nm. The described method was linear over a range of 10-40μg/ml with a correlation coefficient (r2) of 0.9998 for Ivermectin and a range of 100-400μg/ml with a correlation coefficient (r2) of 0.9998 for Clorsulon. Validations of the proposed method were carried out for its accuracy, precision, linearity and range, specificity, LOD and LOQ according to ICH guidelines. A stability-indicating study was also carried out and indicated that this method can also be used for purity and degradation evaluation of these formulations that occurred due to temperature, humidity and time. the method has been successfully applied for the analysis of drugs in formulation.},
 year = {2018}
}

Copy | Download

TY  - JOUR
T1  - Development and Validation for HPLC Method of Assay of Lvermectin and Clorsulon in Combined Pharmaceutical Dosage Form
AU  - Mahmoud Mohamed Ali
AU  - Elfatih Elbashir
AU  - Mohamed N. Abdalaziz
Y1  - 2018/01/16
PY  - 2018
N1  - https://doi.org/10.11648/j.ijhnm.20170306.11
DO  - 10.11648/j.ijhnm.20170306.11
T2  - International Journal of Homeopathy & Natural Medicines
JF  - International Journal of Homeopathy & Natural Medicines
JO  - International Journal of Homeopathy & Natural Medicines
SP  - 45
EP  - 55
PB  - Science Publishing Group
SN  - 2472-2316
UR  - https://doi.org/10.11648/j.ijhnm.20170306.11
AB  - Stability indicating-HPLC method has been developed for simultaneous estimation of Ivermectin and Clorsulon in their combined dosage form. For RP-HPLC method, all the standard and sample solutions were prepared in methanol. A RP-HPLC method has been developed and subsequently validated for simultaneous estimation of Ivermectin and Clorsulon in their combination product. The proposed RP-HPLC method utilizes a Thermo BDS C-18 (15cm x 4.6mm, 5 μm) column, mobile phase consisting of acetonitrile, methanol and purified water in the proportion of 60: 30:10 (v/v/v), and UV detection at 245 nm. The described method was linear over a range of 10-40μg/ml with a correlation coefficient (r2) of 0.9998 for Ivermectin and a range of 100-400μg/ml with a correlation coefficient (r2) of 0.9998 for Clorsulon. Validations of the proposed method were carried out for its accuracy, precision, linearity and range, specificity, LOD and LOQ according to ICH guidelines. A stability-indicating study was also carried out and indicated that this method can also be used for purity and degradation evaluation of these formulations that occurred due to temperature, humidity and time. the method has been successfully applied for the analysis of drugs in formulation.
VL  - 3
IS  - 6
ER  -

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