Study of forced degradation of ciprofloxacin hcl indicating stability using RP-HPLC method

The present study describes the degradation behavior of ciprofloxacin HCl which was investigated under different stress conditions viz acidic, basic, oxidation, UV radiation and thermal conditions. The degradation products were analyzed by HPLC using C-18 column (25 cm x 4.6 mm, 5 μm, Phenomenex Inc.). Forced degradation of the drug product was carried out as per the ICH guidelines. It was found that in alkaline condition i.e. in 0.1N NaOH at 700C for 4 hours, the degradation of ciprofloxacin HCl was about 24%. In acidic condition (0.1 N HCl at 70°C for 4 h), the degradation was somewhat slower than in alkaline condition and it was found about 20%. In oxidation degradation (3% H₂O₂ at 70°C for 4 h) of ciprofloxacin HCl was somewhat significant in compare with acidic and alkaline condition and it was found about 40%. The percentage of drug degradation of ciprofloxacin HCl under UV radiation for 5 days and in thermal condition at 60°C for 24hr was about 30% and 10% respectively.