Pharmaceutical quality evaluation and quantification of metal impurities in multisource levofloxacin tablets registered in Nigeria
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West African Journal of Pharmacy
Background: Levofloxacin, a synthetic broad-spectrum fluoroquinolone antibacterial agent has many generics available as tablet and has placed health practitioners in dilemma of generic substitution. Furthermore, the serious toxic effect of some metals has made the quantification in dosage forms essential. Objectives: The post market surveillance study on fifteen brands of 500 mg levofloxacin tablets registered in Nigeria was aimed at assessment of the quality and heavy metal impurities present in the tablets. Methods: The quality assessment of the tablets was based on evaluation of the physicochemical parameters using standard methods. The assessment of selected heavy metal impurities in all the brands of levofloxacin tablets was carried out using the atomic absorption spectrophotometer for lead, cadmium, nickel, selenium, copper, iron, manganese and zinc. Mercury and arsenic were quantified using the Inductively Coupled Plasma-Optical Emission Spectrometer (ICP-OES). Results: Eight brands (53.3%) passed all the physical tests while 46.7% failed at least one of the tests. Two brands failed the percentage purity test. Forty-two percent of all the generics can be substituted for the innovator brand; while all the brands manufactured in Nigeria passed the similarity tests and could be substituted for the innovator brand. None of the brands contained more than the oral Permissible Daily Exposure (PDE). Among class 1 heavy metals, lead was absent in the generics of levofloxacin tablet while cadmium, mercury and arsenic though were present, were less than the PDE even at daily dose of 1000 mg. Conclusion: The three brands manufactured in Nigeria passed the similarity tests and could be substituted for the innovator brand. All the brands of levofloxacin tablet contained some metal impurities, however, they were within permissible limit. Post market surveillance study of medicinal agents is a source of very important information for health practitioners.
Pharmaceutical Analysis , Levofloxacin , Metal impurities , Pharmaceutical quality , Dissolution profiles , Research Subject Categories::PHARMACY::Pharmaceutical chemistry
Aderonke A. Adepoju-Bello, Chukwuemeka P. Azubuike, Aderonke Amupitan, Cynthia Ugorji (2019). Pharmaceutical quality evaluation and quantification of metal impurities in multisource levofloxacin tablets registered in Nigeria. West African Journal of Pharmacy, 30(2): 81-92-25.