Article Subject
Chemistry
Abstract

Levofloxacin is a fluoroquinolone antibiotic that fights bacteria in the body. Levofloxacin is 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%.

Keywords
Levofloxacin
known impurities
HPLC Method
United States of Pharmacopoeia.
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