A Validated Stability – Indicating Liquid Chromatographic Method for Secnidazole

Abstract

The research work describes development of stability – indicating reverse phase – HPLC method for Secnidazole in the presence of its degradation products, generated from forced degradation studies. Secnidazole was subjected to forced degradation under acidic, basic, photolytic and oxidative conditions. Successful separation of drug from degradation products formed under forced degradation was achieved on a C 18 column (250 mm × 4.6 mm, 5 mcm) using methanol : water (60 : 40 v/v) as a mobile phase at a flow rate of 1mL/min. The detection was carried out at 310 nm. The method was validated for linearity, range, accuracy and precision.The developed method can be used to evaluate quality of regular production samples and also to test stability samples of secnidazole tablets. The intra and inter day results at each level were subjected to one way ANOVA  and F values at each level were obtained as a ratio of between mean square and within mean square. The F values were found to be within limits. And the t-test value was obtained as 1.9725.