Determination of Voriconazole and its Degradation products in Pharmaceutical formulations using High Performance Liquid Chromatography with Ultra-Violet Detection

[摘要] Simple, sensitive and accurate stability indicating analytical method has been developed and validated for determination of voriconazole and its degradation products using RP-HPLC method with ultra-violet detection. The resulting method was applied for determination of voriconazole tablets (Vfend®). The procedure was developed and validated under acidic, basic, oxidative and photo-irradiated conditions. The compounds were separated on C18 column using 0.05M disodium hydrogen phosphate buffer (pH 5.5) : acetonitrile (1:1, v/v) as a mobile phase. at a flow rate of 1.0 ml per min and UV detection at 255 nm, the run time  was less than 15 minutes The calibration curves were linear between 6.0 and 60 µg/ml. The proposed method was simple, highly sensitive, precise, accurate and, is useful for routine quality control analysis and stability testing. It was found that voriconazole was  more sensitive to the basic conditions, photodegradation was observed only under severe conditions of light exposure and oxidation may also appear, however, it was stable in acidic medium.

[学科分类] 分析化学

[关键词] Assay;Stability indicating method;Voriconazole;HPLC.