Abstract :
Analytical method development and validation are the continuous and interdependent
task associated with the research and development, quality control and quality assurance
departments. Analytical procedures play a critical role in equivalence and risk
assessment, management. It helps in establishment of product specific acceptance
criteria and stability of results. Validations demonstrate that the analytical procedure is
suitable for its intended purpose. Literature survey reveals that the analytical methods
based on UV spectrometry, RP-HPLC & HPTLC for the determination of Levofloxacin
individually and in combination with other drugs. The methods were validated according
to ICH guideline in terms of accuracy, precision, robustness, and other aspects of
analytical validation. The developed methods are simple, sensitive and reproducible and
can be used for the routine analysis of Levofloxacin in bulk and Tablet dosage form.
Keyword :
Levofloxacin, Literature Survey, Method Development, Validation, ICH Guidelines.