Quality control studies on some commercially available brands of ciprofloxacin tablets in Anambra State

Abstract

Ciprofloxacin is a synthetic flouroquinolone derivative with broad spectrum antibacterial activity. It is widely used in the treatment of urinary tract infection, lower respiratory tract infection, bacterial diarrhoea, skin and soft tissue, bone and joint infections, gonorrhea and also in surgical prophylaxis. This study is aimed at assessing the quality of eight brands of Ciprofloxaxin (Ciproxamed, Ciprogud, Cisepro, Ciprofaith, Acipro, Nemel, Cipronol and Biocipro) tablets marketed in Anambra State, South Eastern Nigeria. The following official and non official tests were carried out on all the selected brands: disintegration time, dissolution rate, weight uniformity, content of active ingredient, friability, hardness (also known as crushing strength) and thickness. The result showed that the mean disintegration time for all the selected tablets was foundto be within specified limits of USP. In the weight uniformity test, twenty tablets of each selected brand were collected at random. The brands A2 (Ciprogud) and A7(Cipronol) with standard deviation 13.6470 and 11.1916 respectively, failedthetest, while others A1 (Cipromaxed), A3 (Cisepro), A4 (Ciprofaith), A5 (Acipro), A6 (Nemel Cipro), A8 (Biocipro) withstandard deviation 2.7961, 3.7191, 4.9468, 4.6597, 2.5644 respectively, passed. In the dissolution test,all the brands met the Pharmacopoeial specification, except A1 (Cipromaxed), A5 (Acipro) and A8 (Biocipro). In the content of API test, all thebrands tested met the specification. All the brands tested passed the friability specification. In the hardness test, all brands of ciprofloxacin tablets tested were within the limit range of between 5 kgF (minimum) and 8 kgF (maximum).