Development and validation of novel UV spectrophotometric determination of levofloxacin hemi hydrate in bulk and pharmaceutical dosage forms

摘要

The objective of this research was to develop and validate a simple, rapid, accurate and economical UV Spectrophotometric method for determination of levofloxacin hemi hydrate in bulk and marketed formulation. In Water, the λmax of the drug was found to be 286.4 nm. In the proposed method, levofloxacin hemi hydrate follows linearity in the concentration range 4 –10 μg/ml with a correlation coefficient (R2) greater than 0.997 .The method was validated by following the analytical performance parameters suggested by the International Conference on Harmonization (ICH). All validation parameters were within the acceptable range. Under experimental conditions described, calibration curve, assay of tablets and recovery studies were performed. Parameters of validation prove the precision of the method and its applicability for the determination of Levofloxacin Hemi hydrate in pharmaceutical tablet formulations. The method is fast and is suitable for high throughput analysis of the drug.