title: Speciation of antimony (III) and antimony (V) using hydride generation for meglumine antimoniate pharmaceutical formulations quality control.
abstract: The pentavalent antimonies, mainly the meglumine antimoniate, are recommends as first-choice medicines for leishmaniasis therapy. In this work we described the development of formulations of meglumine antimoniate injectable medication, as well as the analytical methodology used in the selective determination of Sb(III) and Sb(Total) by hydride generation - inductively coupled plasma atomic emission spectrometry (HG-ICP-AES) and ICP-AES, respectively. On that purpose the analytical methodology was developed focusing on the HG-ICP-AES technique. The formulations using propylene glycol/water as vehicles in a 20:80 proportion were more appropriate for subsequent use in industrial scale. These formulations also showed a lower variation on Sb(III) percentage, no need of buffer solution to stabilize the formulation and no influence of the autoclaving in the quality of the product. The results of the development of the analytical methodology point out the proposed method as an efficient alternative for the determination of Sb(III) in the presence of large quantities of Sb(V) in injectable solutions of meglumine antimoniate, in a selective, linear, accurate and precise manner. In addition, the method showed a low limit of quantification, less interference of the matrix, and more resilience than batch techniques proposed in the Brazilian Pharmacopeia.
authors.affiliation: Departamento de Medicamentos, Instituto Nacional de Controle de Qualidade em Saúde-Fiocruz, Fiocruz, Brasil. lmcabral@pharma.ufrj.br
authors.forename: Lúcio Mendes
authors.initials: LM
authors.lastname: Cabral
authors.forename: Vânia Neves Moreira
authors.initials: VN
authors.lastname: Juliano
authors.forename: Luiza Rosario Sousa
authors.initials: LR
authors.lastname: Dias
authors.forename: Camila Braga
authors.initials: CB
authors.lastname: Dornelas
authors.forename: Carlos Rangel
authors.initials: CR
authors.lastname: Rodrigues
authors.forename: Michele
authors.initials: M
authors.lastname: Villardi
authors.forename: Helena Carla
authors.initials: HC
authors.lastname: Castro
authors.forename: Terezsa Cristina Dos
authors.initials: TC
authors.lastname: Santos
mesh_terms: D000965:Antimony / Q000032:analysis*; D000981:Antiprotozoal Agents / Q000737:chemistry* / Q000592:standards; D002626:Chemistry, Pharmaceutical / Q000592:standards; D017022:Flow Injection Analysis / Q000379:methods*; D008536:Meglumine / Q000737:chemistry* / Q000592:standards; D000077485:Meglumine Antimoniate; D009942:Organometallic Compounds / Q000737:chemistry* / Q000592:standards; D011786:Quality Control; D013054:Spectrophotometry, Atomic / Q000379:methods*
chemical_list: D000981:Antiprotozoal Agents; D009942:Organometallic Compounds; D008536:Meglumine; D000077485:Meglumine Antimoniate; D000965:Antimony