DEVELOPMENT AND VALIDATION OF A HIGH PERFORMANCE LIQUID CHROMATOGRAPHIC METHOD FOR SIMULTANEOUS DETERMINATION OF THE IMPURITIES THYMINE AND THYMIDINE IN STAVUDINE BULK DRUG

被引：5

作者：

da Silva, Gisele Rodrigues ^{[1
]}

Condessa, Felipe Antonacci ^{[1
]}

Pianetti, Gerson Antonio ^{[1
]}

Nunan, Elziria de Aguiar ^{[1
]}

Moreira de Campos, Ligia Maria ^{[1
]}

机构：

[1] Univ Fed Minas Gerais, Fac Farm, Dept Produtos Farmaceut, BR-31270901 Belo Horizonte, MG, Brazil

来源：

QUIMICA NOVA | 2008年 / 31卷 / 07期

关键词：

HPLC; stavudine; impurities;

D O I：

10.1590/S0100-40422008000700016

中图分类号：

O6 [化学];

学科分类号：

0703 ;

摘要：

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 0.5-5.0 mu g/mL. The quantitation limits were 0.021 mu g/mL for thymine and 0.134 mu g/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.

引用

收藏

页码：1686 / 1690

页数：5

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