Development and Validation of an HPLC-UV Method for the Determination of Levofloxacin from a Prolonged–Release Mesh Implant in Rat Blood
Abstract
Levofloxacin (LVX) is a broad-spectrum antibiotic whose systemic administration can be limited by adverse effects and suboptimal drug levels at infection sites. Implantable drug-loaded meshes offer a promising strategy for localized, prolonged delivery. This study developed and validated a simple, rapid, and reliable high-performance liquid chromatography with ultraviolet detection (HPLC-UV) method for quantifying LVX in rat blood to support the preclinical evaluation of a prolonged-release LVX-loaded polypropylene mesh. The method utilized a Zorbax SB-C18 column with an isocratic mobile phase of acetonitrile:0.1% orthophosphoric acid (80:20, v/v) at a flow rate of 1.4 mL/min, with detection at 296 nm. Validation according to ICH Q2(R2) guidelines demonstrated excellent linearity (R² = 0.999) over 1–8 µg/mL, accuracy (mean recovery 99.68%), and precision (intra- and inter-day CV < 0.3%). The limits of detection and quantification were 0.3 µg/mL and 1.0 µg/mL, respectively. The validated method was successfully applied to quantify LVX in rat plasma samples collected over 10 days post-implantation, confirming its suitability for pharmacokinetic studies of implant-based antibiotic delivery systems. This method provides a practical and robust analytical tool for routine preclinical assessment of LVX release and systemic exposure from localized delivery devices.
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Evidence Hub reads this as a preprint, done in animal, not in people. Its evidence level is 5 of 5 (Very low · case / narrative / animal / in vitro / in silico). Case reports, narrative reviews, and animal, cell or computer-model studies give the weakest evidence for human health.
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