Original Articles
Thilakkumar Thiyagarajan, Nara
Abstract
A reverse phase liquid chromatographic (RP-LC) method was developed for the quantification of Idebenone and its related impurities in drug substance. The method was optimized in a Zorbax SB C18 stationary phase for the separation of known impurities with excellent detection limit in (i.e. less than 75 ng mL-1) the drug substance. A linear gradient elution was involved with the water-acetonitrile-trifluoroacetic acid as mobile phase. The flow rate, wavelength was set as 1.0 mL min-1 and 215 nm respectively. The stability indicating capability of the developed method was demonstrated using the stressed sample at hydrolysis, oxidative, thermal and photolytic conditions. The developed RP-LC method was validated in compliance with ICH requirements. The developed method can be used for the determination of synthetic and degradation impurities in the regular quality control analysis for the drug substance.