Analysis and Standardization of Levofloxacin Substance
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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.
Keywordslevofloxacin substance analysis standardization high-performance liquid chromatography HPLC contaminants R-ofloxacin residual solvents gas-liquid chromatography GLC
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