Stress-Induced Degradation Profiling of Satranidazole Using Stability-Indicating RP-HPLC Method and LC-MS Characterization.

A stability-indicating reverse-phase high-performance liquid chromatographic (RP-HPLC) method was developed and validated for quantitative estimation of satranidazole in bulk drug and tablet dosage form, followed by LC-MS characterization of stress-induced degradation products. Chromatographic separation was achieved on a HiQ Sil C18 column (250 × 4.6 mm, 5 μm) using methanol:0.1% formic acid in water (60:40, v/v) as mobile phase at a flow rate of 1.0 mL/min with UV detection at 317 nm. The method exhibited satisfactory linearity over 5-30 μg/mL with a correlation coefficient of 0.999. Stress-induced degradation studies performed under acidic, alkaline, oxidative, thermal, and photolytic conditions demonstrated significant degradation under alkaline and photolytic stress. The developed method successfully resolved satranidazole from its degradation products. LC-MS analysis enabled tentative characterization of major degradants and facilitated the proposal of probable degradation pathways. The developed method is suitable for routine stability assessment and pharmaceutical quality control of satranidazole formulations.