High performance liquid chromatographic determination of astemizole in pharmaceutical dosage forms

Abstract

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 C₁₈ column (250 × 4.6 mm) with a mobile phase of acetonitrile - 0.1 % orthophosphoric acid, pH adjusted to 3.9 (80:20 <i>v</i><i>/ </i><i>v</i>).<i> </i>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 μg 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.