Development and application of stability indicating RP-HPLC method for the determination of Me Cobalamin in pharmaceutical formulations

摘要

The present work describes a simple and fast stability indicating reversed phase high performance liquid chromatography (RP-FIPLC) method for the quantitative determination of mecobalamin, in pure and pharmaceutical tablet formulations. The chromatographic separation was achieved by the optimized mobile phase consisting of methanol and water (90 :.10) at pH 4.0 on shimpack column. (250 mm x 4.6 mm, 5.0 mu m particle size). The flow rate was kept at 1.0 ml/min, and the injection volume was 20 mu L. The eluted compounds were monitored at 265 nm using a UV detector. The developed method separates mecobalamin and its degradation products within a run time of 5 min. The drug shows degradation under acidic, basic, photo oxidative and neutral conditions. Linearity of the method was found to be 5-75 mu g/ml with correlation co-efficient of 0.9998. The proposed method was validated according to ICH guidelines with respect to accuracy, precision, linearity, specificity, robustness, limits of detection and quantification.