title: Validated HPLC determination of 4-dimethylaminoantipyrine in different suppository bases.
abstract: Suppositories are important tools for individual therapy, especially in paediatrics, and an instrumental assay method has become necessary for the quality control of dosage units. The aim of this work was to develop a rapid, effective high-performance liquid chromatography method to assay aminophenazone in extemporaneous suppositories prepared with two different suppository bases, adeps solidus and massa macrogoli. With a novel sample preparation method developed by the authors, 4-dimethylaminoantipyrine was determined in these suppository bases with 95-105% recovery. The measurements were carried out on a Shimadzu Prominence ultra high-performance liquid chromatography system equipped with a 20 μl sample loop. The separation was achieved on a Hypersil ODS column, with methanol, sodium acetate buffer (pH 5.5±0.05, 0.05 M, 60:40, v/v) as the mobile phase at a flow rate of 1.5 ml/min. The chromatograms were acquired at 253 nm. The chromatographic method was fully validated in accordance with current guidelines. The presented data demonstrate the successful development of a rapid, efficient and robust sample preparation and high-performance liquid chromatography method for the routine quality control of the dosage units of suppositories containing 4-dimethylaminoantipyrine.
authors.affiliation: Institute of Pharmaceutical Analysis, Faculty of Pharmacy, University of Szeged, H-6720 Szeged, Somogyi u. 4., Hungary.
authors.forename: E
authors.initials: E
authors.lastname: Kalmár
authors.affiliation: Generic R&D Division, TEVA Pharmaceuticals Ltd, Debrecen, H-4042 Debrecen, Pallagi út 13., Hungary.
authors.forename: B
authors.initials: B
authors.lastname: Kormányos
authors.affiliation: Institute of Pharmaceutical Analysis, Faculty of Pharmacy, University of Szeged, H-6720 Szeged, Somogyi u. 4., Hungary.
authors.forename: G
authors.initials: G
authors.lastname: Szakonyi
authors.affiliation: Institute of Pharmaceutical Analysis, Faculty of Pharmacy, University of Szeged, H-6720 Szeged, Somogyi u. 4., Hungary.
authors.forename: G
authors.initials: G
authors.lastname: Dombi
keywords: 4-dimethylantipyrine; HPLC; analytic sample preparation; suppositories; validation studies