Fast and New Microbiological Method for Evaluating the Potency of Marbofloxacin-Based Tablets.

BACKGROUND: Marbofloxacin (MAR) is an antimicrobial belonging to the fluoroquinolone class and is marketed in the form of tablets. There is no microbiological monograph in official compendia to evaluate the potency of the final product. Furthermore, the literature is scarce in this context. OBJECTIVE: The objective is to develop and validate a microbiological method by turbidimetry to evaluate the potency of MAR-based tablets, based on the principles of green analytical chemistry. METHODS: Purified water-ethanol (9 + 1, v/v) was used as diluent to prepare the MAR solutions at concentrations of 0.25, 0.8, and 2.56 µg/mL, brain heart infusion (BHI) broth as culture media, E. coli American Type Culture Collection (ATCC) 25922 at 10% and incubation in a shaker at 37°C for 4 h were used in the method. RESULTS: The method was: linear in the range of 0.25 to 2.56 µg/mL; selective against the sample adjuvants; precise (intra-day RSD 2.26%, inter-day RSD 3.49%, and inter-analyst RSD 3.59%); accurate with a recovery of 100.20%; and robust against changes in culture medium volume in the tube, shaker rotation, and incubation temperature in the shaker. The potency of MAR tablets was 96.98% using the proposed method. CONCLUSION: The turbidimetric method developed is a new, fast, and optimized option to the routine QC of MAR in tablets, since it allows the evaluation of the drug's potency in the final product and can be used to complement the results of the physicochemical analysis, in addition to being a green and sustainable alternative. HIGHLIGHTS: The work shows an ecological and green alternative to the routine microbiological pharmaceutical analysis of MAR tablets.

An Overview of Analytical Methods for the Quantification of Marbofloxacin in Pharmaceutical, Biological, and Food Matrixes.

BACKGROUND: Marbofloxacin (MAR), a second-generation fluoroquinolone, is used in veterinary medicine in the form of tablets. It has a broad spectrum of action, low toxicity, and limited development of bacterial resistance. The analytical methods available in the literature become more important since MAR in tablets does not have a monograph in official compendiums. OBJECTIVE: Our purpose is to review the methods according to the analyzed matrix and place them according to the conditions used in the scope of green analytical chemistry, in addition to discussing possible gaps and opportunities for the development of new methods. RESULTS: MAR, being an antimicrobial, presents both physicochemical (93%) and microbiological (7%) methods in the literature. Among the methods found, 53% are for analysis of food matrixes using preferably HPLC and TLC-MS, 27% are for analysis of biological matrixes and 20% are for analysis of pharmaceutical matrixes, and in both HPLC is preferably used. CONCLUSION: Therefore, there is still a gap in the literature in relation to other analytical methods for the analysis of MAR, which are faster, such as microbiological turbidimetry, sustainable, such as miniaturized methods, and ecologically correct, such as those that do not use toxic organic solvents. HIGHLIGHTS: A review of the analytical methods available in the literature for assessing the quality of MAR and MAR-based products in which the methods, as well as new opportunities for analysis according to green analytical chemistry, were described and discussed.