SPECTROPHOTOMETRIC & RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF LEVOFLOXACIN & ORNIDAZOLE

摘要

An accurate, precise and reproducible UV-spectro-photometric methods and liquid chromatographic assay method were developed and validated for the determination of Levofloxacin and Ornidazole in tablet dosage form. Spectrophotometric estimation was done by simultaneous equation method and 50% methanol as solvent. In this method λ_max for LEVO and OZ were selected at 293.5nm and 318nm. RP-HPLC analysis was carried out using Prontosil C-18 column (4.6 x 250mm, 5μ particle size) and mobile phase composed of Acetonitrile : 0.05% Ortho-phosphoric acid in water pH 3.0 (45:55% v/v)at a flow rate of 1.0 ml/min and chromatogram was recorded at 303 nm. Linearity was evaluated over the concentration range of 4 -20 μg/ml and 8-40μg/mL for LEVO and OZ in both UV spectrophotometric and RP-HPLC method (the value of r2= 0.999 found were by both the methods for LEVO and OZ). The developed methods were validated according to ICH guidelines and values of accuracy, precision and other statistical analysis were found to be in good accordance with the prescribed values therefore the both methods can be used for routine monitoring of LEVO and OZ in industry in the assay of bulk drug and tablets.