title: Development of a gas chromatography method for the determination of isotretinoin and its degradation products in pharmaceuticals.
abstract: This paper describes the development of a gas chromatography (GC) method used for the assay of isotretinoin in its isolated form and in pharmaceutical formulations. Isotretinoin soft and hard gelatin capsules were prepared with various excipients. The performance of the proposed gas chromatography method was compared to that of traditional high performance liquid chromatography (HPLC) systems for this substance, and the GC parameters were established based on several preliminary tests, including thermal analysis of isotretinoin. Results showed that gas chromatography-flame ionization detector (GC-FID) exhibited a separation efficiency superior to that of HPLC, particularly for separating isotretinoin degradation products. This method was proven to be effectively applicable to stability evaluation assays of isotretinoin and isotretinoin based pharmaceuticals.
authors.affiliation: Lab. Tecnologia Farmaceutica, Faculdade de Farmacia, Universidade Federal de Goias, Av. Universitaria, 74605-220 Goiania, GO, Brazil. emlima@farmacia.ufg.br
authors.forename: Eliana Martins
authors.initials: EM
authors.lastname: Lima
authors.forename: Danielle G Almeida
authors.initials: DG
authors.lastname: Diniz
authors.forename: Nelson R
authors.initials: NR
authors.lastname: Antoniosi-Filho
mesh_terms: D002849:Chromatography, Gas; D004055:Differential Thermal Analysis; D015474:Isotretinoin / Q000032:analysis*; D007641:Keratolytic Agents / Q000032:analysis*; D012015:Reference Standards; D014212:Tretinoin / Q000032:analysis
chemical_list: D007641:Keratolytic Agents; D014212:Tretinoin; D015474:Isotretinoin