ICH guideline (Q2R1)

Enrofloxacin (EFX) is a third generation Fluoroquinolone with a broad spectrum antibacterial activity. Enrofloxacin hydrochloride is 1-cyclopropyl-7-(4-ethylpiperazin-1-yl)-6-fluoro-4-oxo-1, 4-dihydroquinoline-3-carboxylic acid. A Sensitive, simple and rapid reverse phase high performance liquid chromatographic method was developed for the determination of Enrofloxacin (EFX) in tablet dosage form. The chromatographic separation was performed on a Kromasil C-18 column (250mm x 4.6 mm x 5µ) in isocratic mode using phosphate buffer pH 3:Methanol (40:60 v/v), pH adjusted to 3.0 using orthophosphoric acid as mobile phase at a flow rate of 1.0 ml/min with column temperature 30 OC. The quantification was performed at 280 nm. The method showed good linearity over the concentration range of 5-25 µg/ml with correlation coefficient r2 0.9996. LOD and LOQ was found to be 1.0 and 3.0. The developed RP HPLC method was applied to EFX in tablet dosage form and results were found to be in agreement with the label claim.