Development and validation of stability indicating rp-hplc method for estimation of balofloxacin in bulk and tablet dosage form

Objective: The objective of the method was to develop a simple, rapid, efficient, cost effective and reproducible, stability indicating (RP-HPLC) Reverse Phase High Performance Liquid Chromatography method for the estimation of Balofloxacin in bulk and tablet dosage form. Methods: The RP-HPLC analysis was carried out on an Enable C 18 G column with a mobile phase of Potassium dihydrogen orthophosphate (pH adjusted to 2.5 with 0.1 M ortho phosphoric acid) and Acetonitrile in the ratio of 75:25% v/v. The analyte was detected at 293 nm using PDA detector. The method was validated in terms of linearity, accuracy, precision, LOD (Limit of Detection), LOQ (Limit of Quantification) and robustness as per ICH guidelines. Results: The method was found to be linear in the range of 10-120 µg/ml. Limit of detection and limit of quantitation was found to be 0.793 and 2.405 µg/ml respectively. Recovery was found to be in the range 100.268- 101.077 % and precision less than 2%. The developed method was successfully applied for the estimation of Balofloxacin in marketed tablet formulation (Baloforce TAB) and percentage assay was found to be 101.690 %. Forced degradation studies were performed under different conditions. The drug was degraded in acidic, basic, oxidative, UV light and sunlight conditions. The peaks of degraded products were well resolved from the actual drug. The results obtained prove that the developed method is a stability indicating method. Conclusion: The developed RP-HPLC method was simple, rapid, accurate, precise and stability indicating for the estimation of Balofloxacin in bulk and tablet dosage form.