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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
pharmacology, toxicology and pharmaceutics
Determination of cefixime by a validated stability-indicating HPLC method and identification of its related substances by LC-MS/MS studies
Scientia Pharmaceutica, Volume 81, No. 2, Year 2013
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Description
Cefixime is an important cephalosporin antibiotic that easily decomposes and releases different related substances in preparation and storage steps. The objective of the current study was to develop a simple, precise, and accurate isocratic liquid chromatography (LC) method for the determination of cefixime in the presence of its related substances generated from thermal stress in the bulk drug. The chromatographic conditions were comprised of a reversed-phase C18 column (4.6 × 250 mm, 5 μm) with a mobile phase composed of water: acetonitrile (85:15 v/v, with 0.5% formic acid) and ultraviolet detection (UV). Some thermal degradation products were identified using a proposed liquid chromatography-mass spectrometry method. Five peaks (A, B, C, D, and E impurities based on British Pharmacopoeia) were known and a few unknown peaks appeared in the thermal stress solution of cefixime. The linear regression analysis data for the calibration plot of the LC-UV method showed a good linear relationship in the concentration range 0.9-1000.0 μg mL-1. The recovery of the optimized method was between 94.6 and 98.4% and the inter- and intra-day relative standard deviations were less than 3.3%. The obtained results shown in the LC-UV proposed method can be conveniently used in a quality control laboratory for routine analysis of cefixime for the assay and related substances, as well as for the evaluation of stability samples of bulk drugs. © Reddy et al.; licensee Österreichische Apotheker-Verlagsgesellschaft m. b. H., Vienna, Austria.
Authors & Co-Authors
Talebpour, Zahra
Iran, Tehran
Alzahra University
Pourabdollahi, Hakimeh
Iran, Tehran
Alzahra University
Rafati, Hasan
Iran, Tehran
Shahid Beheshti University
Abdollahpour, Asem
Iran, Tehran
Jaber Pharmaceutical Companies
Bashour, Yusef
Iran, Tabriz
Instrumental Analytical Chemistry Laboratory
Aboul-Enein, Hassan Y.
Egypt, Giza
National Research Centre
Statistics
Citations: 25
Authors: 6
Affiliations: 5
Identifiers
Doi:
10.3797/scipharm.1301-15
ISSN:
00368709
e-ISSN:
22180532
Research Areas
Environmental
Study Approach
Quantitative