QUALITY CONTROL ASSESSMENT OF DIFFERENT BRANDS OF OFLOXACIN TABLETS MARKETED IN NIGERIA
FESTUS CHIGOZIE ODO, CHINWE MERCY ONAH*, EDWIN OGECHUKWU OMEJE, CHARLES
OKEKE NNADI
Department of Pharmaceutical and Medicinal Chemistry, Faculty of Pharmaceutical Sciences University of Nigeria,
Nsukka, Enugu State. Nigeria.
Afr. J Pharm Res Dev; Volume 13(1): 120-126 (2021)
ABSTRACT
Drug counterfeiting has caused the global health sector a lot of setbacks. Because antibiotics are the most used
in Nigeria, it is expedient to regularly assess the authenticity of all antibiotics sold in the Nigerian market. This study
evaluated the conformity to standard requirements, of five different brands of ofloxacin tablets marketed in Nigeria
in terms of the quantity of the active ingredients and the quality of the products in general. Five branded ofloxacin
tablets were compared with the standard specification in terms of their drug release pattern, the content of active
ingredient and the integrity of the dosage form. Dissolution time and disintegration tests were performed in
simulated gastric fluid (SGF) and simulated intestinal fluid (SIF) of pH 4.5 and 1.2 respectively without enzymes.
An assay of the active ingredient was done to ascertain the conformity of the quantity of the active ingredient
compared with the standard specification. Also, the friability test, hardness test, weight uniformity test was carried
out. The result shows that all the tablet brands conformed to specifications except OFLO-A which failed both the
weight uniformity (C.V 10.3 % and an assay of active ingredient (116 %) tests. The average percentage label claim
of all the brands was found to be 102.98 ± 10.09. To a great extent, the assessed brands of ofloxacin tablets were
found to conform to official standards.
Email of correspondence: onah.chinwe@unn.edu.ng
KEYWORDS: Ofloxacin; Quality assessment; Disintergration time.