Comparative quality assessment of generic brands of ceftriaxone sodium injection marketed in Ibadan, South- West Nigeria

Abstract

Ceftriaxone is a broad-spectrum bactericidal agent. Due to lower prices of generic brands of ceftriaxone sodium as compared to the innovator brand, the populace mostly uses them and hence, the need to comprehensively investigate and compare the pharmaceutical quality of innovator with generic brands marketed in Ibadan, South-West Nigeria. Standard physical and chemical tests for quality control of parenterals as stipulated by the British Pharmacopoeia 2013 were performed on 13 brands. The basic functional groups were identified by Infrared spectrophotometry. A Liquid Chromatography method was used for quantitative determination of ceftriaxone sodium. The bactericidal activity of ceftriaxone sodium and brands were investigated by using clinical isolates of Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus and Bacillus species. The FTIR spectra for the innovator and the generics were superimposable. For clarity test, almost all samples were observed to give a clear solution, but unclear solution was seen in samples B, E and I. The LC method was linear over a concentration range of 7.8125 – 250 μg/mL (r² = 0.9996). Microbiological efficacy using MIC determination of the generic products evaluated against several clinically significant organisms gave conclusive results with the generic products showing equivalent efficacy to the reference formulation except in few cases. The results obtained from this study conform to that of the British Pharmacopoeia specifications, giving an indication that all the sampled generics are pharmaceutically equivalent. There is need to improve on local production and to increase the post-marketing surveillance, as some products do not have NAFDAC registration numbers.

Keywords: Ceftriaxone; Physicochemical analysis; Pharmaceutical equivalence; Microbiological analysis