Development of a Stability-indicating RP-UPLC Method for determination of Fidarestat in Bulk Drug

Abstract

An accurate, precise, robust and selective stability-indicating liquid chromatographic (UPLC) method has been developed for the monitoring of Fidarestat in the presence of its forced degradants. The drug was subjected to hydrolysis (acid and alkali), oxidation, photolysis and thermal stress conditions. The drug degraded significantly under hydrolytic and oxidative stress conditions, whereas it was found to be stable in photolytic and thermal conditions. The mobile phase consisted of 0.1% formic acid and methanol in the ratio of (50:50, v/v). The flow rate was 0.5ml/min, column temperature 30°C, the injec¬tion volume was 20µL, and sample was monitored at 283nm using a PDA detector over a concentration range of 20 - 180μg/ml with correlation coefficient of 0.997. The developed LC method was validated as per ICH guideline Q2 (R1). The proposed method was found to be successively applied for the quality control of Fidarestat in bulk drug analysis.