A Validated Quantitative Estimation and Stability Indicating Reversed-phase-high Performance Liquid Chromatography Method for Balofl oxacin in Bulk and its Tablet Formulation

Abstract

This paper describes the development of a stability-indicating reversed-phase-high performance liquid chromatography (RP-HPLC) method for balofl oxacin (BFX) in the presence of its degradation products generated from forced decomposition studies. The drug substance was found to be susceptible to stress conditions of acid, base, oxidation, wet heat, and photo degradation. The drug was found to be stable to the dry heat condition attempted. Successful separation of the drug from the degradation products formed under stress conditions was achieved on a Zorbax C 18 column (150 mm × 4.6 mm id, 5 microns particle size) using methanol-water pH adjusted to 2.5 by orthophosphoric acid (40:60, v/v) as the mobile phase at a fl ow rate of 0.5 mL/min at 30°C temperature. Quantifi cation was achieved with photodiode array detection at 293 nm over the concentration range 50-150 μg/ml with mean recovery of 100.0 ± 0.53% for BFX by the RP-HPLC method. Statistical analysis proved the method is repeatable, specifi c, and accurate for estimation of BFX. Because the method could effectively separate the drug from its degradation products, it can be used as a stability-indicating method. Key words: Balofl oxacin, reversed-phase-high performance liquid chromatography, orthophosphoric acid, validation.