Analysis and Standardization of Levofloxacin Substance
- 111 Downloads
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
- 1.V. V. Arkhipov and V. K. Prozorova, Farmateka, No. 7, 23 – 38 (2004).Google Scholar
- 2.V. A. Krechkov, Klin. Mikrobiol. Antimikrob. Khimioter., 6(3), 282 – 285 (2004).Google Scholar
- 3.V. N. Charushin, E. B. Gorbunov, G. L. Rusinov, et al., A Means of Preparing 7,8-Difluoro-2,3,-dihydro-3-methyl-4H-1,4-benzoxazine [in Russian], Russian Federation patent No. 2434005; Byul. Izobret., No. 32 (2011).Google Scholar