LAUSR

A stability-indicating RP-HPLC method for methylcobalamin determination was developed. Stress degradation under variable conditions was carried out. Methylcobalamin had pronounced susceptibility to hydrolysis under acidic, alkaline, and photolytic conditions; further study of photolytic degradation kinetics and pH rate profiling over pH range 2-11 was carried out. Photodegradation of methylcobalamin followed zero-order kinetics with half-life 0.99hour equivalent to 1971.53 lux. Methylcobalamin followed pseudo first order kinetics upon exposure to acidic and alkaline hydrolysis with highest stability at pH 5 and least stability at pH 2. Optimization of chromatographic conditions was performed using two level full factorial design, chromatographic analysis was executed using Inertsil® column (250×4.6 mm, 5μm) maintained at 25◦ C. Elution was carried out using 25mM potassium dihydrogen phosphate (pH adjusted with phosphoric acid to 3.8): methanol: acetonitrile (55:35:10, v/v) as mobile phase. The flow rate was 1.0 mL/min. Detection was carried out at 220 nm using diode array detector. The method was validated as per ICH guidelines; the linearity was over concentration range 2-160 μg/mL with coefficient of determination 0.9995. The method was effectively applied for determination of methylcobalamin in Cobalvex® ampoule, cobal® tablet, cobal-F® tablet and methyltechon® oral dissolvable film without interfering from excipients within run time six minutes. This article is protected by copyright. All rights reserved.