stability indicating hplc method for simultaneous estimation of epalrestat and methylcobalamin in tablet dosage form

Research Article
Mili Patel*, Bhakti J. Ladva, Sagar S. Patel, Dr. Bhavesh S. Nayak, Hetal K. Patel and Bhumi R. Patel
DOI: 
xxx-xxx-xxx
Subject: 
Medical
KeyWords: 
Epalrestat, Methylcobalamin, Stability Studies, Forced Degradation, HPLC
Abstract: 

Forced degradation study was carried out and a newly developed method is applicable to degradation analysis of drug. A chromatographic separation of drug as well as its degradants was achieved using spherisorb CNRP, 4.6 × 250mm, 5µm C18 column with Mobile phase of Acetonitrile: 0.05 M Potassium Dihydrogen Phosphate Buffer pH 4.0 adjusted with ortho phosphoric acid (60: 40, V/V). Drug and degradants were monitored at detection wavelength of 292nm, the flow rate was 1 ml/min, injection volume was 20 µl. Retention time of Epalrestat and Methylcobalamin were about 3.26 min and 4.92 min respectively. Both the drugs were subjected to acid, alkali, oxidation, thermal and photo degradation. The degradation studies indicates Epalrestat to be more susceptible to acid hydrolysis while Methylcobalamin to be more susceptible to photo hydrolysis. The degradation products were well resolved from the pure drug with significant differences in their retention time values.