Novel HPLC method for Levofloxacin and Its known impurities in Tablets dosage form

Abstract

Levofloxacinis a fluoroquinolone antibiotic that fights bacteria in the body. Levofloxacinis used to treat different types of bacterial infections. Simple HPLC method for Levofloxacin and six known impurities was developed and validated. Buffer: 8.5g ammonium acetate, 1.25g cupric sulphate and 1.g L-Isoleucine in 1000ml water. Mobile phase: Buffer and methanol 70:30 v/v; Diluent: Mobile phase; Column: Inertsil ODS-3V C18, 250*4.6mm, 5μ; Injection volume: 25μL; Column temperature 42°C; Flow rate: 0.7ml/min; Run time: 60min; Detector: 340nm. System suitability limits are NMT 10%RSD for 5 replicates and tailing factor NMT 1.8. Method validation was performed with precision, specificity, accuracy, linearity, limit of detection and quantification, ruggedness and robustness. Finalized method produced linear response in the specification limit was 0.998 to 1.000 correlation coefficient for levofloxacin and percentage recovery was found to be 98.00% to 102.0%.