Development and validation of the methodology for evaluation of itraconazole in pharmaceutical products by HPLC

Química Nova

Azevedo, Roberta de Cássia Pimentel¹  Araújo, Magali Benjamim de¹  Universidade Federal de Alfenas, Alfenas, Brasil¹  Cazedey, Edith Cristina Laignier¹  Silva, Érika de Fátima¹ 

关键词: itraconazole;    validation;    HPLC.;   

DOI  :  10.1590/S0100-40422007000400004

学科分类：化学（综合）

来源: Sociedade Brasileira de Quimica

【 摘 要 】

Itraconazole is a synthetic antifungal drug administered orally with a broad spectrum of activity against mycotic infections. The present work consists of the development and validation of analytical methodology for evaluation of itraconazole in pharmaceutical products by high performance liquid chromatography. The separation was made using the reversed-phase column LC-18, acetonitrile/diethylamine 0.05% v/v, 60:40 v/v, pH 8.0 as mobile phase, methanol as solvent and detection and quantification at 254 nm. The results here obtained show that the analytical methodology is accurate, reproducible, robust and linear over the concentration range 8.0-12.0 µg/mL of itraconazole. The method was applied to pharmaceutical capsules containg itraconazole pellets and showed to be efficient, yielding good results.

【 授权许可】

Unknown