Quantitative Determination of Levofloxacin in Ophthalmic Solution by High- Performance Liquid Chromatography

Abstract

Abstract Levofloxacin, as a prototypical of the third generation of fluoroquinolones, is an antimicrobial agent routinely administrated for treating bacterial keratitis. Levofloxacin is available under different trade names as liquid pharmaceutical formulations, such as infusions and eye drops. This paper reports a fast, simple, accurate and precise HPLC technique for levofloxacin determination in liquid pharmaceutical formulations. The HPLC method was applied with Photodiode Array Detectors, and measurements were conducted at 294 nm UV-Vis wavelength. The technique was developed to immediately estimate levofloxacin in the Oftaquix 5 mg/mL ophthalmic formulation. The ODS-phenyl column was used and maintained at 30 ± 2 °C and 294 nm λmax conditions. The mixture of acetonitrile:0.1% trifluoroacetic acid (18:82 v/v) was used as a mobile phase with a flow rate of 1.5 ml/min. Levofloxacin peak was eluted at 9.5 min with good resolution. The method was validated in relation to system suitability, accuracy, linearity, and precision in agreement with ICH and FDA guidelines. The results indicated that the established HPLC-DAD method in this study is simple and accurate and can be applied for routine analysis of levofloxacin amounts in pharmaceutical formulations and bioequivalence studies in quality control departments and the pharmaceutical industry.