Original Articles
L. Samba Siva Rao, P. Madhavan
Abstract
A simple, linear, rapid, precise and stability-indicating analytical method was developed for the estimation of related substances and degradants of Carvedilol API and tablets. The chromatographic separations were achieved using high performance liquid chromatograph (Inertsil ODS 3V, 150mm X 4.6mm, ID with 5 microns particles column) employing mixture of 0.1% Trifluoro acetic acid, methanol and acetonitrile (500:300:200v/v) as mobile phase in an isocratic elution mode with a 1.5 mL/min flow rate was chosen. Five impurities were eluted within fifteen minutes of run time. The column temperature was maintained at 55ºC and a detector wavelengths of 220nm (Amino impurity –E) & 240nm (Carvedilol & other impurities) was employed. Carvedilol was exposed to acid, base, thermal, photolytic, and oxidative stress conditions. The stressed samples were analyzed by the proposed method. The degradation of Carvedilol was observed under, oxidative hydrolysis, base hydrolysis, thermal and photolytic. The drug was found to be stable in all other stress conditions applied. Successful separation of the drug from organic impurities and degradation products formed under forced degradation was achieved. The developed HPLC method to determine the related substances and assay of Carvedilol can be used to evaluate the quality of regular production samples.It can be also used to test the stability samples of Carvedilol.