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Development and Validation for RP-HPLC Method of Assay of Omeprazole Capsules Formulation

Received: 10 August 2017    Accepted: 5 September 2017    Published: 9 January 2018
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Abstract

Omeprazole is a potent proton pump inhibitor for the treatment of various acid-related gastrointestinal disorders. simple, selective and rapid reversed phase high performance liquid chromatographic (RP-HPLC) method for the analysis of Omeprazole has been developed and validated. The separation was achieved from HPLC column (ZORBAX, XDB, C-18 (150×4.6 mm, 5 micron) with a mobile phase consisting of HPLC grade acetonitrile and phosphate buffer solution (pH 7.4) in the ratio of (60:40 v/v) at a flow rate of 0.5 ml/min and runtime 10 min with UV detector at 302nm. The method was specific and it was observed that no interference with diluents. The proposed method was accurate with 100.95% recovery omeprazole and precise (% RSD of area of system precision, % RSD of assay of method precision were found to be 0.14% and 0.37% respectively). From the linearity study the correlation coefficient is found to be 0.9988, which indicated that the method was linear over 25% to 175% range. The method was found robust for possible changes. Therefore, this method can be used as a more convenient and efficient option for the analysis of Omeprazole to establish the quality of the drug substance during routine analysis with consistent and reproducible results.

Published in American Journal of Chemical Engineering (Volume 6, Issue 1)
DOI 10.11648/j.ajche.20180601.11
Page(s) 1-6
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

Omeprazole, HPLC, Validation, Mobile Phase

References
[1] Indian Pharmacopoeia, Vol. II, Govt. of India, Ministry of Health and Family Welfare. New Delhi; Published by The Controller of Publications; 1996.
[2] Forte, JG; Lee, (1977). HC "Gastric adenosine triphosphates: A review of their possible role in HCl secretion". Gastroenterology 73 (4 Pt 2): 921–6. PMID20386.
[3] Snaeder, W, (1996). Drug prototypes and their exploitation. Wiley. pp. 414–5.
[4] Hemenway, Jeffrey Nm, (2007). "Case Study: Omeprazole (Prilosec®)". Prodrugs. Biotechnology: Pharmaceutical Aspects. pp. 1313–21. doi:10.1007/978-0-387-49785-3_49. ISBN978-0-387-49782-2.
[5] Shin, Jai Moo; Munson, Keith; Vagin, Olga; Sachs, George, (2008). "The gastric HK-ATPase: Structure, function, and inhibition". Pflügers Archiv - European Journal of Physiology 457 (3): 609–22. doi:10.1007/s00424-008-0495-4. PMC3079481. PMID18536934.
[6] British Pharmacopoeia, (2013). Vol.1, the British Pharmacopoeia Commission, London.
[7] United States Pharmacopia, 30-NF-25 31 (4) 1100.
[8] Sweetman SC. Martindale, (2002) – The Complete Drug Reference, (3 rd Edition) Pharmaceutical Press, London, 1241-1243.
[9] Girish Malhotra, (2010). "Chemical Process Simplification: Improving Productivity and Sustainability" ch 5 to be published John Wiley & Sons.
[10] Kalakonda Sri Nataraj, Mohammad Badrud Duza, Kalyani Pragallapati, Dussa Kiran Kumar, (2012). International Current Pharmaceutical Journal, 1(11): 366-369.
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  • APA Style

    Mahmoud Mohamed Ali, Eshtiag Abdalla Ibrahim, Mohamed N. Abdalaziz. (2018). Development and Validation for RP-HPLC Method of Assay of Omeprazole Capsules Formulation. American Journal of Chemical Engineering, 6(1), 1-6. https://doi.org/10.11648/j.ajche.20180601.11

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    ACS Style

    Mahmoud Mohamed Ali; Eshtiag Abdalla Ibrahim; Mohamed N. Abdalaziz. Development and Validation for RP-HPLC Method of Assay of Omeprazole Capsules Formulation. Am. J. Chem. Eng. 2018, 6(1), 1-6. doi: 10.11648/j.ajche.20180601.11

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    AMA Style

    Mahmoud Mohamed Ali, Eshtiag Abdalla Ibrahim, Mohamed N. Abdalaziz. Development and Validation for RP-HPLC Method of Assay of Omeprazole Capsules Formulation. Am J Chem Eng. 2018;6(1):1-6. doi: 10.11648/j.ajche.20180601.11

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  • @article{10.11648/j.ajche.20180601.11,
      author = {Mahmoud Mohamed Ali and Eshtiag Abdalla Ibrahim and Mohamed N. Abdalaziz},
      title = {Development and Validation for RP-HPLC Method of Assay of Omeprazole Capsules Formulation},
      journal = {American Journal of Chemical Engineering},
      volume = {6},
      number = {1},
      pages = {1-6},
      doi = {10.11648/j.ajche.20180601.11},
      url = {https://doi.org/10.11648/j.ajche.20180601.11},
      eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.ajche.20180601.11},
      abstract = {Omeprazole is a potent proton pump inhibitor for the treatment of various acid-related gastrointestinal disorders. simple, selective and rapid reversed phase high performance liquid chromatographic (RP-HPLC) method for the analysis of Omeprazole has been developed and validated. The separation was achieved from HPLC column (ZORBAX, XDB, C-18 (150×4.6 mm, 5 micron) with a mobile phase consisting of HPLC grade acetonitrile and phosphate buffer solution (pH 7.4) in the ratio of (60:40 v/v) at a flow rate of 0.5 ml/min and runtime 10 min with UV detector at 302nm. The method was specific and it was observed that no interference with diluents. The proposed method was accurate with 100.95% recovery omeprazole and precise (% RSD of area of system precision, % RSD of assay of method precision were found to be 0.14% and 0.37% respectively). From the linearity study the correlation coefficient is found to be 0.9988, which indicated that the method was linear over 25% to 175% range. The method was found robust for possible changes. Therefore, this method can be used as a more convenient and efficient option for the analysis of Omeprazole to establish the quality of the drug substance during routine analysis with consistent and reproducible results.},
     year = {2018}
    }
    

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  • TY  - JOUR
    T1  - Development and Validation for RP-HPLC Method of Assay of Omeprazole Capsules Formulation
    AU  - Mahmoud Mohamed Ali
    AU  - Eshtiag Abdalla Ibrahim
    AU  - Mohamed N. Abdalaziz
    Y1  - 2018/01/09
    PY  - 2018
    N1  - https://doi.org/10.11648/j.ajche.20180601.11
    DO  - 10.11648/j.ajche.20180601.11
    T2  - American Journal of Chemical Engineering
    JF  - American Journal of Chemical Engineering
    JO  - American Journal of Chemical Engineering
    SP  - 1
    EP  - 6
    PB  - Science Publishing Group
    SN  - 2330-8613
    UR  - https://doi.org/10.11648/j.ajche.20180601.11
    AB  - Omeprazole is a potent proton pump inhibitor for the treatment of various acid-related gastrointestinal disorders. simple, selective and rapid reversed phase high performance liquid chromatographic (RP-HPLC) method for the analysis of Omeprazole has been developed and validated. The separation was achieved from HPLC column (ZORBAX, XDB, C-18 (150×4.6 mm, 5 micron) with a mobile phase consisting of HPLC grade acetonitrile and phosphate buffer solution (pH 7.4) in the ratio of (60:40 v/v) at a flow rate of 0.5 ml/min and runtime 10 min with UV detector at 302nm. The method was specific and it was observed that no interference with diluents. The proposed method was accurate with 100.95% recovery omeprazole and precise (% RSD of area of system precision, % RSD of assay of method precision were found to be 0.14% and 0.37% respectively). From the linearity study the correlation coefficient is found to be 0.9988, which indicated that the method was linear over 25% to 175% range. The method was found robust for possible changes. Therefore, this method can be used as a more convenient and efficient option for the analysis of Omeprazole to establish the quality of the drug substance during routine analysis with consistent and reproducible results.
    VL  - 6
    IS  - 1
    ER  - 

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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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