Mise au point et validation d’une méthode de dosage par hplc du principe actif et des produits de dégradation dans les crèmes à base de naftifine

Abstract

Naftifine is a topical antifungal mainly indicated for the treatment of dermatophytoses, also used to treat cutaneous candidiasis and pityriasis versicolor. It acts as both fungicidal and fungistatic depending on the concentration. The objective of this study is to develop a reversed-phase HPLC method to be used for the assay of the active ingredient and degradation products in naftifine HCl creams. The HPLC method was performed under optimized chromatographic conditions on a Brisa LC C18 column (150×4.6×3 μm) with a flow rate of 1.2 ml/min, UV detection at 270 nm, and a gradient elution mode using a mobile phase composed of an acetate buffer pH 7 and acetonitrile (ACN). The retention time was 15.41 min. Validation of the method according to ICH guidelines concluded that it is specific, linear (R²=0.9994), accurate (recovery=102.8%), and reproducible (CV(J1)=1.3%; CV(J2)=1.41%). The limit of detection and limit of quantification were determined as 0.14 µg/ml and 0.42 µg/ml, respectively. Thus, this validated HPLC method proves to be reliable and suitable for quality control of naftifine HCl creams, allowing precise analysis of the active ingredient and its degradation products