Evaluation of quality of generic brands of enrofloxacin available on the Ugandan market

Abstract

ABSTRACT This study intended to evaluate the quality of enrofloxacin brands available on the Ugandan market for veterinary use. Enrofloxacin is a fluoroquinolone antibiotic with a broad-spectrum activity commonly used for the treatment of various bacterial infections in animals and poultry. Two batches of eight different brands of generic enrofloxacin were purchased from Veterinary pharmacies in Kampala and Mbarara city. Standard physical and chemical tests for quality surveillance were performed on the brands according to the methods outlined in the US Pharmacopoeia 2013. High Performance Liquid Chromatography using a UV-VIS detector was used for quantitative determination of enrofloxacin in the various brands. All brands assessed were clear solutions showing a statistically significant difference between the obtained pH value and the expected pH value of 7 as per USP specification at a P≤ 0.05. The product label on both the primary and secondary pack of the brands had clearly stated the proprietary name, product strength, manufacture and expiry dates, batch number, specific storage conditions, name of manufacturer and country of origin of the drug. However, some key compendial information was lacking on the label with only 37.5% (3/8) indicating the generic name, 87.5% (7/8) indicating the route of administration while 25% (2/8) indicated the composition on the label. HPLC analysis revealed that the mean drug concentration in all the brands were within compendial specifications. The clarity of all the brands was also within compendial limits.