FORCED DEGRADATION STUDIES FOR ETHAMBUTOL BY RP-HPLC

Abstract

Literature survey of ethambutol reveals no stability indicating analytical method being reported for estimation, either in bulk or in a pharmaceutical dosage form. Therefore, a stability indicating analytical method needed to be developed and validated. In the current research, a RP-HPLC method was developed to separate ethambutol from its degradation products. Ethambutol is exposed to stressors like hydrolysis, oxidation, neutral (water), and photolysis decomposition, and the degradation products were separated using an ODS Hypersil C-18 column. Buffer: acetonitrile was used as mobile phase at a flow rate of 0.5 mg mL-1. Ethambutol showed a retention time of 6.1 min. Validation study was performed as per guidelines prescribed by ICH Q2(R1). Pharmaceutical industries can use the developed method to perform routine drug analysis on pharmaceutical dosage forms.