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Memórias do Instituto Oswaldo Cruz
Fundação Oswaldo Cruz, Fiocruz
ISSN: 1678-8060
EISSN: 1678-8060
Vol. 103, No. 2, 2008, pp. 130-137
Bioline Code: oc08023
Full paper language: English
Document type: Research Article
Document available free of charge

Memórias do Instituto Oswaldo Cruz, Vol. 103, No. 2, 2008, pp. 130-137

 en Speciation of antimony (III) and antimony (V) using hydride generation for meglumine antimoniate pharmaceutical formulations quality control
Cabral, Lúcio Mendes; Juliano, Vânia Neves Moreira; Dias, Luiza Rosario Sousa; Dornelas, Camila Braga; Rodrigues, Carlos Rangel; Villardi, Michele; Castro, Helena Carla & Cristina dos Santo, Tereza

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.

Keywords
antimony - stibine - hydride generation - inductively coupled plasma atomic emission spectrometry - formulation - analysis - stabilization

 
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