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Assessment of the quality control parameters of five brands of ciprofloxacin hydrochloride caplets in Nigeria


T J Okonkwo
E O Afieroho
A Odigwe
P O Osadebe

Abstract



The hardness, friability, weight uniformity, disintegration time, content of active ingredient, and bactericidal characteristics of five brands of ciprofloxacin HCl caplets in Nigeria were evaluated using official methods. Brands: A, B and C, exhibited comparable bactericidal activity (p<0.05) against Salmonella paratyphimurium and could be used interchangeably; while A, and D exhibited comparable bactericidal activity (p < 0.05) against the Gram-positive Staphylococcus aureus and may be used interchangeably as well. All five brands passed the disintegration time test with disintegration time range of 105.00 - 482.00 sec; and the friability test with a range of percent weight loss on abrasion (B values) of 0.014 - 0.161 %. Only three brands; B, D, and E, passed the content of active ingredient test with percentage absolute drug contents of 94.08, 106.68 and 89.96 %, respectively. Brand B, however passed the weight uniformity test with percentage deviation value of 4.9277 %. None of the brands evaluated met fully the BP or USP requirements for caplets.

Keywords: Quality control; Bioactivity; Interchangeability; Ciprofloxacin caplets

Journal of Pharmacy and Bioresources Vol. 3 (2) 2006: pp. 83-88

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eISSN: 0189-8442