In vitro Comparative Quality Assessment of Four Brands of Moxifloxacin 400 mg Tablets Marketed in Yemen

Abstract

Context:  Moxifloxacin is a fourth generation fluoroquinolone antibiotic, having activity against gram-negative (Escherichia coli, Haemophilus influenza, Klebsiella pneumonia, Proteus mirabilis and Moraxella catarrhalis) and gram-positive (Staphylococcus aureus, Streptococcus anginosus, Enterococcus faecalis, Pneumococci, and Streptococcus pyogenes) microorganisms.Objective : The objective of the current study was to characterize the quality control parameters and cost effective analysis of four selected different brands of moxifloxacin 400 mg tablets. Methods: All four selected brands were coded as IB^*, A, B, and C and the price were noted as YR 5700. ($9.5), 4200 ($7), 2000 ($3.33) and 2000 ($3.33) per 5 tablets, respectively. By using official and non-official tests, all the brands were evaluated for physical and chemical characteristics such as hardness, weight variation, friability, disintegration, dissolution, content uniformity and assay using already reported HPLC and spectrophotometric methods. The brand IB^* was considered as reference, due to its good physical and chemical properties and its dissolution profile was compared with other brands, using model independent approach (similarity factor- f2), to compare the dissolution profile of generic drug products with reference. There is a large variation in the price of reference and other generic drugs available in the local market of Yemen. Results: The results of the identification tests confirmed that all of the samples contained the active medicinal ingredients that were listed. Weight variation tests revealed that all samples were within the USP standard limits. The active pharmaceutical components quantitative assay revealed that all brands of moxifloxacin tablets were within the label claim limit of 90% to 105 percent.Conclusion: It was concluded that low cost local brands of moxifloxacin 400 mg tablets can be used as an alternative in case of un-available brands in the market. This study will be helpful to the healthcare practitioners to prescribe other generic brands of moxifloxacin, as the cost is 50% less in comparison with reference which may reduce the medication cost to the patients.