{"id":4583,"date":"2023-07-25T13:12:56","date_gmt":"2023-07-25T13:12:56","guid":{"rendered":"https:\/\/wapcpharm.org\/journal\/?p=4583"},"modified":"2023-07-28T13:27:57","modified_gmt":"2023-07-28T13:27:57","slug":"west-african-journal-of-pharmacy-2017-28-2-26-34","status":"publish","type":"post","link":"https:\/\/wapcpharm.org\/journal\/west-african-journal-of-pharmacy-2017-28-2-26-34\/","title":{"rendered":"West African Journal of Pharmacy (2017) 28 (2) 35-51"},"content":{"rendered":"\t\t
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Impurities profiling of brands of ceftriaxone sodium injection marketed in Ibadan, Southwest Nigeria<\/b><\/p>

\u00a0<\/p>

Olajire A. Adegoke , Aderonke O. Korede , Adosraku R. Kwame and Cecilia I. Igwilo<\/p>

1Department of Pharmaceutical Chemistry, Faculty of Pharmacy, University of Ibadan, Ibadan, Nigeria,<\/span><\/p>

2Multidisciplinary Central Research Laboratory, University of Ibadan, Ibadan, Nigeria,<\/p>

3Department of Pharmaceutical Chemistry, Faculty of Pharmacy & Pharm. Sciences,\u00a0<\/span>Kwame Nkrumah University of Science and Technology, Kumasi, Ghana;<\/span><\/p>

4Department of Pharmaceutics and Pharmaceutical Technology, Faculty of Pharmacy, University of Lagos, Nigeria<\/span><\/p>

\u00a0<\/p>

Correspondence author: Olajire A. Adegoke<\/p>

Emails: jireade@yahoo.com Phone: +2348036381625<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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ABSTRACT<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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Background:<\/b> Several factors can affect the effectiveness of a drug in therapy. One of such is the presence of impurities.<\/span><\/p>

Objectives:<\/b> Based on the current useful utility status of ceftriaxone injection as an antibacterial agent, a\u00a0comprehensive impurity profiling of thirteen brands was carried out in order to provide a basis for specifying\u00a0<\/span>appropriate storage conditions.<\/span><\/p>

Methods: <\/b>The profiling was carried out by developing a new liquid chromatographic method with UV\u00a0detection. Factors that could affect the separation method such as elution mode, pH, flow rate, detection\u00a0<\/span>wavelength and type of organic modifier were studied. Validation studies comprising calibration curve, LOD\u00a0<\/span>and LOQ determination, accuracy and repeatability were determined. The method was successfully applied\u00a0<\/span>to the determination of ceftriaxone and impurities in 13 brands of ceftriaxone injections.<\/span><\/p>

Results: <\/b>The developed method involved separation of ceftriaxone and major impurities within 15 minutes\u00a0using gradient elution with KH PO (pH 7.5) and methanol (flow rate, 1 mL\/min). Separation was achieved on 2 4\u00a0<\/span>2\u00a0<\/span>a C-18 column at 220 nm. Linearity was obtained within the range 7.8 \u2013 250 \u03bcg\/mL (r = 0.9996) with LOD and\u00a0<\/span>LOQ as 74.56 and 225.9 ng\/mL respectively. Relative errors from the intra- and inter-day assessment were\u00a0<\/span>generally less than 2%. All the brands complied with the content BP specification of 92-108% of ceftriaxone.\u00a0<\/span>However, the impurities content in all the 13 brands were far higher than the 0.2% specified by ICH for the\u00a0<\/span>dose of the drug.<\/span><\/p>

Conclusion:<\/b> There is need for measures to adequately control storage conditions of the injection in order to\u00a0limit impurities content.<\/span><\/p>

Keywords:<\/b> Ceftriaxone, Impurities profiling, Liquid chromatography, Storage conditions<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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\n\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\tDownload <\/span>\n\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"

Impurities profiling of brands of ceftriaxone sodium injection marketed in Ibadan, Southwest Nigeria \u00a0 Olajire A. Adegoke , Aderonke O. Korede , Adosraku R. Kwame and Cecilia I. Igwilo 1Department of Pharmaceutical Chemistry, Faculty of Pharmacy, University of Ibadan, Ibadan, Nigeria, 2Multidisciplinary Central Research Laboratory, University of Ibadan, Ibadan, Nigeria, 3Department of Pharmaceutical Chemistry, Faculty […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"om_disable_all_campaigns":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[233],"tags":[],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/wapcpharm.org\/journal\/wp-json\/wp\/v2\/posts\/4583"}],"collection":[{"href":"https:\/\/wapcpharm.org\/journal\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/wapcpharm.org\/journal\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/wapcpharm.org\/journal\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/wapcpharm.org\/journal\/wp-json\/wp\/v2\/comments?post=4583"}],"version-history":[{"count":5,"href":"https:\/\/wapcpharm.org\/journal\/wp-json\/wp\/v2\/posts\/4583\/revisions"}],"predecessor-version":[{"id":4597,"href":"https:\/\/wapcpharm.org\/journal\/wp-json\/wp\/v2\/posts\/4583\/revisions\/4597"}],"wp:attachment":[{"href":"https:\/\/wapcpharm.org\/journal\/wp-json\/wp\/v2\/media?parent=4583"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/wapcpharm.org\/journal\/wp-json\/wp\/v2\/categories?post=4583"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/wapcpharm.org\/journal\/wp-json\/wp\/v2\/tags?post=4583"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}