Green method for evaluation of marbofloxacin tablets by HPLC and evaluation of interchangeability with UV and turbidimetric methods.

Abstract

Marbofloxacin (MAR) is a veterinary antimicrobial, marketed in injectable solution, oral suspension and tablets. MAR has no monograph for tablets evaluation in official compendiums. HPLC methods present in the literature for evaluating MAR in tablets do not follow the principles of green and sustainable analytical chemistry. A green, clean and sustainable method by HPLC was developed and validated to evaluate the content and stability of MAR in tablets, in addition to comparing it with other methods available in the literature. A C8, 5 µm, 4.6 x 150 mm (ACE®) colunn, purified water with 0.2% formic acid: ethanol (70:30, v/v) as mobile phase, flow rate of 0.7 mL/min at 296 nm were used. The method was linear over a concentration range of 1-10 μg/mL, selective for tablet matrix and forced degradation, precise with relative standard deviations less than 5%, accurate with recovery of 99.99% and robust to changes in the mobile phase, flow rate, wavelength, equipment and column brand. The retention time for MAR was approximately 3.1 minutes. The method can be used in routine analysis of MAR in tablets in chemical-pharmaceutical laboratories. Furthermore, it can be used to verify the stability of MAR-based products and proved to be interchangeable with spectrophotometric method in the UV region and turbidimetric microbiological method. Additionally, it is a clean method, which contemplates green analytical chemistry.