Determination of Levofloxacin in a Pharmaceutical Injectable Formulation by Using HPLC and UV Spectrophotometric Methods

Abstract

The objective of this study was to develop simple and rapid methods for the determination of levofloxacin (LVF) using high performance liquid chromatography and UV spectrophotometry. LVF was separated on a reversed phase Phenomenex^® C18 column (150×4.6 mm i.d., particle size 4 µm), under isocratic elution with a mixture of water:acetonitrile:phosphoric acid 0.025 M, pH adjusted to 3.0 with triethylamine (60∶20∶20, v/v/v), as the mobile phase at room temperature and at a flow rate of 1.0 mL/min. The UV detector was set to 294 nm and UV‐vis spectrophotometer at 292 nm. Both methods allowed the quantification of LVF and showed good linearity (r>0.999) in the studied range. The relative standard deviations (RSD) were 0.66 and 1.0% for HPLC and UV spectrophotometry, respectively. The accuracy determined with HPLC was 100.68 and with UV spectrophotometry was 99.61%. The methods were validated through the parameters of linearity, accuracy, precision, specificity, and robustness. The two proposed methods enabled a quantitative determination of LVF in pharmaceutical injectable formulation.

Keywords:

• Levofloxacin
• RP‐HPLC
• UV spectrophotometry
• Validation