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Title: High performance liquid chromatographic determination of astemizole in pharmaceutical dosage forms
Authors: Basavaiah, K
Charan, V S
Chandrashekar, U
Keywords: Astemizole determination;HPLC;Dosage forms
Issue Date: Jul-2004
Publisher: NISCAIR-CSIR, India
IPC Code: B01D 15/00, A61K
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 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 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.
Page(s): 504-508
ISSN: 0975-0991 (Online); 0971-457X (Print)
Appears in Collections:IJCT Vol.11(4) [July 2004]

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