Orbifloxacin (ORBI) was subjected to different ICH (Q1A(R2)) prescribed stress conditions of thermal stress, hydrolysis, oxidation and photolysis. It was stable to dry heat (60 ÂºC) and photolysis (UV-VIS) in solid form. It showed extensive decomposition under hydrolytic and photolytic conditions in acid, base and neutral solutions. Degradation was also observed in oxidative condition. Degradation products of ORBI formed under different forced conditions were characterized through LCâ€“MS studies. In total, eleven major degradation products (DP1-DP11) were detected. Successful separation of drug and degradation products formed under various stress conditions was achieved on a analytical column SymmetryShield Waters RP18, 5 Âµm, 250 x 4.6 mm using 5% acetic acid and methanol as mobile phase in a gradient mode at flow rate of 0.5 ml/min. The peaks were detected using a PDA detector set at 290 nm. The method was extended to LCâ€“APCI-MS for characterization of the degradation products and the pathways of decomposition were proposed.
Orbifloxacin, Chemistry degradation, SIAM, LC-APCI-MS, Stability
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