Pharmaceutical Quality Assessment of Different Brands of Moxifloxacin 400 mg Tablets Available in Pakistan
Objective: The objective of the current study was to characterize the quality control parameters and cost effective analysis of five selected different brands of moxifloxacin 400 mg tablets. 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.
Method: All five selected brands were coded as M-1, M-2, M-3, M-4 and M-5 and the price were noted as PKR 805.82 ($6.03), 375 ($2.81), 475 ($3.56), 300 ($2.25) and 160 ($1.20) 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 M-1 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 Pakistan.
Results: The results of physical and chemical tests showed that that all brands of moxifloxacin were within the specified limits. The amount of moxifloxacin in all five brands was within the USP specification of not less than 80% at 45 minutes. Similarly, the values of f2 for M-2 (77.20), M-3 (69.56), M-4 (76.98) and M-5 (82.17) indicated that all the brands were found to be similar with reference brand.
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.
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