Study of forced degradation of cefexime trihydrate indicating stability using reversed phase high performance liquid chromatographic (RP-HPLC) method

The present study describes the degradation behaviour of cefixime trihydrate which was investigated under different stress conditions viz acidic, basic,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 0.1 N at 80 oC for 30 min and in 0.01 N NaOH at 80 oC for 8 h, the degradation rate was found as >98% and >60% of drug, resp ectively. In acidic condition (0.1 N HCl at 80 oC for 7 h), the degradation was somewhat slower and it was found about 50%.The drug was degraded about 70% and about 30% under exposing UV radiation for 2.5 h.