Development and Validation for RP-HPLC Method of Assay of Omeprazole Capsules Formulation
American Journal of Chemical Engineering
Volume 6, Issue 1, January 2018, Pages: 1-6
Received: Aug. 10, 2017;
Accepted: Sep. 5, 2017;
Published: Jan. 9, 2018
Views 1603 Downloads 114
Mahmoud Mohamed Ali, Department of Chemistry, Faculty of Pure and Applied Science, International University of Africa, Khartoum, Sudan
Eshtiag Abdalla Ibrahim, 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
Follow on us
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.
Omeprazole, HPLC, Validation, Mobile Phase
To cite this article
Mahmoud Mohamed Ali,
Eshtiag Abdalla Ibrahim,
Mohamed N. Abdalaziz,
Development and Validation for RP-HPLC Method of Assay of Omeprazole Capsules Formulation, American Journal of Chemical Engineering.
Vol. 6, No. 1,
2018, pp. 1-6.
Copyright © 2018 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.
Indian Pharmacopoeia, Vol. II, Govt. of India, Ministry of Health and Family Welfare. New Delhi; Published by The Controller of Publications; 1996.
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.
Snaeder, W, (1996). Drug prototypes and their exploitation. Wiley. pp. 414–5.
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.
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.
British Pharmacopoeia, (2013). Vol.1, the British Pharmacopoeia Commission, London.
United States Pharmacopia, 30-NF-25 31 (4) 1100.
Sweetman SC. Martindale, (2002) – The Complete Drug Reference, (3 rd Edition) Pharmaceutical Press, London, 1241-1243.
Girish Malhotra, (2010). "Chemical Process Simplification: Improving Productivity and Sustainability" ch 5 to be published John Wiley & Sons.
Kalakonda Sri Nataraj, Mohammad Badrud Duza, Kalyani Pragallapati, Dussa Kiran Kumar, (2012). International Current Pharmaceutical Journal, 1(11): 366-369.