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.com
Volume 9
Journal of Analytical & Bioanalytical Techniques
Mass Spectra & Analytika 2018
September 19-20, 2018
September 19-20, 2018 Singapore
World Congress on
Mass Spectrometry and Analytical Techniques
J Anal Bioanal Tech 2018, Volume 9
DOI: 10.4172/2155-9872-C2-031
Quantitative assay of metal impurities and pharmaceutical quality evaluation of multisource
Levofloxacin tablets registered in Nigeria
Aderonke Ayinke Adepoju Bello and Chukwuemeka P Azubuike
University of Lagos, Nigeria
L
evofloxacin is a broad-spectrum antibiotic of the class fluoroquinolone. There are many generics of levofloxacin tablets
available within the drug delivery system globally. This has placed health practitioners in dilemma of generic substitution.
The serious toxic effect of arsenic and mercury has made the quantification in dosage forms necessary today. The post
market surveillance studied on 15 brands of levofloxacin 500 mg tablets registered in Nigeria was aimed at assessment of
the physicochemical quality of the brands and determination of the quantity of selected metal impurities. To determine the
brands that could be substituted for the innovator brand using similarity factor. The concentration of selected metal (Hg
and As) impurities in all the brands of levofloxacin 500 mg (LEV01 to LEV15) tablets were carried out using ICP-OES. The
physicochemical parameters of evaluated using both official (USP) and unofficial standards including uniformity of weight
test, hardness test, friability test, disintegration test, dissolution profiles and quantitative assay was carried out using high
performance liquid chromatography. The concentration of mercury and arsenic in all the brands analyzed is below the
Permissible Daily Exposure (PDE). The results showed that all the brands passed the physical tests except Lev 11, Lev 10 and
Lev 01, 02, 09, 11 that failed the uniformity of weight test, disintegration test and hardness test respectively. Lev 09 failed the
quantitative assay test. Only Lev 3, 6, 7, 8, 11, 13 and 15 can be substituted for the innovator brand Lev 01. All the brands
manufactured in Nigeria (Lev 6, 11, 13) passed the similarity factor, f
2
, test and therefore could be substituted for the innovator
brand. The study showed that the locally manufactured levofloxacin tablets could be substituted for the innovator brand. The
post market surveillance study of medicinal agents is a source of very important information for health practitioners.
adepojubello@yahoo.com