In vitro comparative quality assessment of different brands of norfloxacin tablets available in Jimma, Southwest Ethiopia
Authors Hambisa S, Belew S, Suleman S
Received 2 October 2018
Accepted for publication 10 February 2019
Published 17 April 2019 Volume 2019:13 Pages 1241—1249
Checked for plagiarism Yes
Review by Single-blind
Peer reviewers approved by Dr Amy Norman
Peer reviewer comments 3
Editor who approved publication: Dr Qiongyu Guo
Solomon Hambisa,1 Sileshi Belew,2,3 Sultan Suleman2,4
1Department of Pharmacy, College of Health Sciences, Mizan-Tepi University, Mizan-Teferi, Ethiopia; 2Jimma University Laboratory of Drug Quality (JuLaDQ), Jimma University, Jimma, Ethiopia; 3School of Veterinary Medicine, Jimma University, Jimma, Ethiopia; 4School of Pharmacy, Jimma University, Jimma, Ethiopia
Background: Pharmaceuticals play a pivotal role in maintaining human health and promoting well-being. However, safety, efficacy, and quality of the drugs should be ascertained to provide a desired pharmacological effect.
Aim: The aim of the present study was to determine the quality as well as the physicochemical equivalence of nine brands of norfloxacin tablets marketed in Jimma, Ethiopia.
Methods: Nine norfloxacin brands were subjected to in vitro tests associated with quality of tablet dosage form, and the tests were conducted according to procedures described in the United States Pharmacopeia (USP).
Results: This study indicated that all brands of norfloxacin complied with the USP for uniformity of weight, friability, hardness, and assay of active ingredient. However, two of the nine brands evaluated failed to release 80% of their drug contents within 30 minutes as outlined in the USP. Correspondingly, all of the brands studied were within the specification for hardness test. Furthermore, different dissolution profile comparison methods have proven the similarity in dissolution profile of Negaflox and Norcin with the comparator product (Trizolin). Mathematical models-dependent approaches have shown that the drug release data fit well to the Weibull release model.
Conclusion: The physicochemical evaluation showed that all the norfloxacin brands met the quality specification with respect to uniformity of weight, hardness, friability, and assay. With regard to dissolution test, two brands of norfloxacin were found to be out of the specified pharmacopeial requirement. The study also revealed the similarity in the dissolution profile of two brands of norfloxacin with the comparator product.
Keywords: norfloxacin, assay, uniformity of weight, hardness, friability, dissolution profile, Jimma
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