Study of forced degradation of ciprofloxacin HCl indicating stability using RP-HPLC method | Abstract

Der Pharma Chemica
Journal for Medicinal Chemistry, Pharmaceutical Chemistry, Pharmaceutical Sciences and Computational Chemistry

ISSN: 0975-413X


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

Author(s): Most. Umme Bushra, Md. Nazmul Huda, Mehedi Mostafa, Md. Zakir Sultan and Asma Rahman

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 × 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 70oC for 4 h), the degradation was somewhat slower than in alkaline condition and it was found about 20%. In oxidation degradation (3% H2O2 at 700C 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 600C for 24hr was about 30% and 10% respectively.


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