నైరూప్య

Area under curve method development and validation for estimation of balofloxacin in bulk and tablet dosage form

Pritam S.Jain, Devendra S.Girase, Pankaj R.Bari, Sanjay J.Surana

Simple, precise and economical UV - spectrophotometric method has been developed for the estimation of Balofloxacin in pharmaceutical dosage form. Method applied was area under curve (AUC) in which area under curve was integrated in the wavelength range of 280.40 – 304.0 nm. Calibration curves were plotted for method by using instrumental response at selected wavelengths and concentrations of analyte in the solution. Linearity for the detector response was observed in the concentration range of 2-12 µg/ml for the method. Tablet formulation was analyzed and % assay determined was 99.60% – 101.69%. Accuracy and precision studies were carried out and results were satisfactory. The results of the analysis were validated statistically. Limit of detection and limit of quantitaiton were determined for method. The method was validated by following the analytical performance parameters suggested by the International Conference on Harmonization.All validation parameters were within the acceptable range. The developed method was successfully applied to estimate the amount of Balofloxacin in pharmaceutical formulation.