ICH guidance in practice: establishment of inherent stability of secnidazole and development of a validated stability-indicating high-performance liquid chromatographic assay method

The degradation behaviour of secnidazole was investigated under different stress degradation (hydrolytic, oxidative, photolytic and thermal) conditions recommended by International Conference on Harmonisation (ICH) using HPLC and LC-MS. A stability-indicating HPLC method was developed that could separate drug from degradation products formed under various conditions. Secnidazole was found to degrade significantly in alkaline conditions, oxidative stress, and also in the presence of light. Mild degradation of the drug occurred in acidic and neutral conditions. The drug was stable to dry heat. Resolution of drug and the degradation products formed under different stress studies were successfully achieved on a C-18 column utilizing water-methanol in the ratio of 85:15 and at the detection wavelength of 310 nm. The method was validated with respect to linearity, precision (including intermediate precision), accuracy, selectivity and specificity. (C) 2004 Elsevier B.V. All rights reserved.