Abstract

The behavior of ciprofloxacin HCl under various stress conditions, including acidic, basic, oxidative, UV radiation, and temperature environments, is described in the current work. HPLC was used to examine the degradation products using a C-18 column (25 cm × 4.6 mm, 5 µm, Phenomenex Inc.). The drug product underwent forced degradation in accordance with ICH principles. It was discovered that the degradation of ciprofloxacin HCl was around 24% under an alkaline setting, i.e., in 0.1N NaOH at 700C for 4 hours. The deterioration was found to be 20% in the acidic condition (0.1 N HCl at 70oC for 4 hours), albeit somewhat slower than in the alkaline condition. About 40% of the ciprofloxacin HCl was found to be degraded by oxidation (3% H2O2 at 700C for 4 hours), which was rather substantial when compared to acidic and alkaline conditions. The percentage of ciprofloxacin HCl drug degradation under UV light for five days and in heat conditions for twenty-four hours was around thirty percent and ten percent, respectively.

Description