Development and validation of an analytical method for simultaneous determination of fixed-dose combination tablets of lamivudine, zidovudine and nevirapine by hight performance liquid chromatography

Química Nova

Laboratório Farmacêutico do Estado de Pernambuco, Recife, Brasil¹  Silva, Rosali Maria Ferreira da¹  Medeiros, Flávia Patrícia Morais de¹  Lavra, Zênia Maria Maciel¹  Universidade Federal de Pernambuco, Recife, Brasil¹  Rolim Neto, Pedro José¹ 

关键词: fixed-;    dose combination;    validation;    HPLC.;   

DOI  :  10.1590/S0100-40422008000500005

学科分类：化学（综合）

来源: Sociedade Brasileira de Quimica

【 摘 要 】

An analytical method has been developed and validated for the quantitation of lamivudine, zidovudine and nevirapine in the fixed-dose combination film-coated tablet by high performance liquid chromatography, in accordance with RE No. 899/2003, National Sanitary Surveillance Agency. It was based on an isocratic elution system with a potassium phosphate buffer pH 3.0: acetonitrile (60:40 v/v) mobile phase, C18, 250 x 46 mm column, 10µm particle size, λ 270 nm. The statistically evaluated results have shown that the method is specific, precise, accurate, and robust, ensuring the analytical safety of 3TC, AZT and NVP determination, which emerges as a new therapeutic alternative for antiretroviral treatment.

【 授权许可】

Unknown