Journal of separation science vol:24 issue:10 pages:849-855
Clarithromycin is a 6-O-methylated semi-synthetic derivative of erythromycin A, which is more resistant towards acid decomposition. Commercial clarithromycin samples contain several potential impurities arising from the manufacturing process and degradation. A simple, selective, and sensitive isocratic liquid chromatographic method has been developed for the impurity profiling of clarithromycin bulk samples. The method employs a XTerra RP18, 5 mum, 250 x 4.6 mm column thermostated at 56 degreesC. The mobile phase consists of acetonitrile - 0.2 M potassium phosphate buffer pH 6.80 - water (40:3.5:56.5). Several peaks are of unknown identity. The method is stability indicating.