Development and validation a new stability indicating LC method for the quantification of flucytosine

Flucytosine is a fluorinated analogue of cytosine. Flucytosine is an orally effective synthetic anti-mycotic agent used for the treatment of systemic fungal infections produced by yeasts. Flucytosine acts mainly against Candida and Cryptococcus and also against some of the species Cladosporium and Phialophora. A new reverse phase liquid chromatographic method has been proposed for the quantification of Flucytosine in pharmaceutical formulations and the method was validated as per ICH guidelines. Mobile phase consisting of a mixture of water: methanol: acetic acid (50: 50: 0.1 v/v) with a flow rate 1 mL/min and UV detection at 264 nm was used for the assay of Flucytosine. The drug was exposed to different stress conditions such as acidic, alkaline, oxidation and thermal degradation. Linearity was observed over the concentration range 0.5–120 μg/mL with linear regression equation y = 74185x-5852.7 (r² = 0.9999). The LOD was found to be 0.1393 μg/mL and the LOQ was found to be 0.4187 μg/mL. The present method can be applied for the pharmaceutical formulations, kinetics study and bioanalytical studies.