Biological assay and liquid chromatographic method for analysis of moxifloxacin in tablets

• Published in: Journal of AOAC International 2005-07, Vol.88 (4), p.1086-1092
• Main Authors: GUERRA, Fanny L. B, PAIM, Clesio S, STEPPE, Martin, SCHAPOVAL, Elfrides E. S
• Format: Article
• Language: English
• Subjects: Acetonitriles - analysis; Aza Compounds - analysis; Biological and medical sciences; Biological Assay; Chemistry, Pharmaceutical - methods; Chromatography; Chromatography, Liquid - methods; Diffusion; Dose-Response Relationship, Drug; Drug Stability; Drugs; Fluoroquinolones; Food industries; Fundamental and applied biological sciences. Psychology; Hydrogen-Ion Concentration; Light; Liquid chromatography; Methanol - analysis; Methods; Micrococcus luteus - metabolism; Models, Chemical; Moxifloxacin; Phosphoric Acids - analysis; Product/Service Evaluations; Quaternary Ammonium Compounds - analysis; Quinolines - analysis; Reproducibility of Results; Spectrophotometry, Ultraviolet - methods; Tablets; Technology, Pharmaceutical - methods; Testing; Time Factors; Ultraviolet Rays
• ISSN: 1060-3271; 1944-7922
• DOI: 10.1093/jaoac/88.4.1086

A microbiological assay and a liquid chromatographic method were validated for quantitation of moxifloxacin in tablets. The microbiological method consisted of a cylinder-plate agar diffusion assay using Micrococcus luteus ATCC 9341 as the test microorganism and phosphate buffer (0.1M, pH 8.0) as the diluent solution. The response graphs for standard and sample solutions were linear (r = 0.9479), and no parallelism deviations were detected in the tested levels of concentration (4.0, 8.0, and 16.0 microg/mL). The interday precision was 2.73%. Recovery values were between 96.25 and 100.5%. The chromatographic analyses were performed using a Shim-pack CLC-ODS column (250 x 4.6 mm, 5 microm) with a mobile phase consisting of (A) a mixture of phosphoric acid (0.17%, v/v) with tetramethylammonium hydroxide (0.05M) and acetonitrile (95 + 5, v/v) and (B) methanol (55 + 45, v/v) adjusted to pH 3.0. The flow rate was 1.0 mL/min, and detection was made at 294 nm. The method was linear in a range from 12.0 to 42 microg/mL (r = 0.9999), and the interday precision was 1.39%. Recovery ranged between 101.9 and 103.81%. Both validated methods were used to quantify the moxifloxacin content in tablets exposed to ultraviolet radiation, and similar results were obtained.