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Pharmaceutical Chemistry Journal

, Volume 47, Issue 11, pp 620–626 | Cite as

Analysis and Standardization of Levofloxacin Substance

  • M. K. Sedova
  • M. S. Sergeeva
  • M. E. Dudenkova
  • L. M. Gaevaya
  • L. N. Grushevskaya
  • N. I. Avdyunina
  • B. M. Pyatin
Article
  • 112 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.

Keywords

levofloxacin substance analysis standardization high-performance liquid chromatography HPLC contaminants R-ofloxacin residual solvents gas-liquid chromatography GLC 

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Copyright information

© Springer Science+Business Media New York 2014

Authors and Affiliations

  • M. K. Sedova
    • 1
  • M. S. Sergeeva
    • 1
  • M. E. Dudenkova
    • 1
  • L. M. Gaevaya
    • 1
  • L. N. Grushevskaya
    • 1
  • N. I. Avdyunina
    • 1
  • B. M. Pyatin
    • 1
  1. 1.V. V. Zakusov Science Research Institute PharmacologyRussian Academy of Medical SciencesMoscowRussia

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