3 Pharmaceutical Manufacturing Technology Centre, School of Pharmacy, University College,
Received on: 05-10-2017; Revised and Accepted on: 08-11-2017
A stability-indicating reversed-phase HPLC method has been developed, optimized and validatedfor quantitative analysis of degradation products and process impurities of prulifloxacin in the bulk drug. Separation of the drug from possible impurities was achieved by reverse-phase YMC-Pack ODS AQ, 150 x 4.6mm, 5µm particle size column with the mobile phase consisted of A and B, 0.04 M ammonium acetate buffer adjusted to a pH of 3.5 ± 0.05 with acetic acid as solvent A and degassed mixture of 0.04 M ammonium acetate buffer and acetonitrile in the ratio of 80:20 as solvent B, at an flow rate of 0.8 mL/min with UV detection wavelength of 277 nm with 10 µL sample volumes enabled separation of the drug from its degradation products. The retention time of prulifloxacin was found to be 19.04 minutes. The developed method was validated for linearity, accuracy, robustness and system suitability as per guidelines recommended by ICH. Prulifloxacin was subjected to stress conditions such as hydrolysis (acid and base), oxidation (photolysis, and thermal), the stressed samples were analyzed by use of this method. Maximum degradation was observed in acid and base hydrolysis and oxidation. The drug was also susceptible to degradation under photolytic and thermal conditions. The degradation products of PFN were well resolved from main peak thus proving the stability indicating nature of the method. The method developed was suitable for stability indicating nature, in process and quality control analysis which is simple, robust, linear and precise.
N. Padmavathi Bandi et al. RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF RELATED SUBSTANCES IN BULK FORM OF PRULIFLOXACIN AND SUBSEQUENT DEGRADATION STUDIES. J Pharm Res 2017;6(Suppl 2):38-42.