Analysis and Standardization of Levofloxacin Substance.

Amethod for the analysis and standardization of levofloxacin substance synthesized using an original method was developed. The physicochemical properties of batch samples of levofloxacin substance were studied; IR and UV spectra were recorded for identification; contents of contaminants and R-ofloxacin in substance were determined by HPLC; residual solvent contents were determined by GLC. Samples of substance were assayed by HPLC. The shelf life was determined and quality norms were specified for levofloxacin substance; the results were used to prepare a draft pharmacopoeia monograph for levofloxacin substance. [ABSTRACT FROM AUTHOR]