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

• Main Author: Silva,Gisele Rodrigues da
• Publication Date: 2008
• Other Authors: Condessa,Felipe Antonacci, Pianetti,Gérson Antônio, Nunan,Elzíria de Aguiar, Campos,Ligia Maria Moreira de
• Format: Article
• Language: por
• Source: Química Nova (Online)
• Download full: http://old.scielo.br/scielo.php?script=sci_arttext&pid=S0100-40422008000700016
• topic: HPLC; stavudine; impurities

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 C18 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 0.5-5.0 µg/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.