화학공학소재연구정보센터
Indian Journal of Chemical Technology, Vol.11, No.4, 504-508, 2004
High performance liquid chromatographic determination of astemizole in pharmaceutical dosage forms
A rapid, highly sensitive high performance liquid chromatographic method has been developed for the determination of astemizole that is suitable for routine use in quality control. The chromatographic conditions comprised of a reversed-phase C-18 column (250 X 4.6 mm) with a mobile phase of acetonitrile - 0.1% orthophosphoric acid, pH adjusted to 3.9 (80:20 v/v). The flow rate was 1.5 mL min(-1) and uv detection was set at 215 nm. The calibration graph was linear from 5.13 - 405.0 mug mL(-1). The method was validated according to ICH guidelines including the assay of commercially available tablets. Recoveries ranged from 98.10 to 101.90%. The utility and accuracy of the method were further established by parallel determination by a reference method and by recovery studies. The excipients present in the tablets did not interfere.