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BIBTEX RIS

Desenvolvimento e validação de método por cromatografia líquida de alta eficiência para determinação simultânea das impurezas timina e timidina na matéria-prima estavudina

2008; Brazilian Chemical Society; Volume: 31; Issue: 7 Linguagem: Inglês

10.1590/s0100-40422008000700016

ISSN

1678-7064

Autores

Gisele Rodrigues da Silva, Felipe Antonacci Condessa, Gérson Antônio Pianetti, Elzíria de Aguiar Nunan, Lígia Maria Moreira de Campos,

Tópico(s)

Analytical Methods in Pharmaceuticals

Resumo

STAVUDINE BULK DRUG.A HPLC method was developed to quantify thymine and thymidine impurities in stavudine bulk drug.The separation was carried out in isocratic mode using methanol/water (20:80) as mobile phase, a C 18 column and UV detection at 266 nm.The method provided selectivity based on peak purities and resolution among peaks.It was linear over the range of 0.5-5.0µg/mL.The quantitation limits were 0.021 µg/mL for thymine and 0.134 µg/mL for thymidine.The average accuracies of three concentrations ranged from 97.06 to 102.61% and precision was close to 1%.The method showed robustness, remaining unaffected by deliberate variations in relevant parameters.

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