Micellar Liquid Chromatography Coupled with Fluorometric Detection for the Determination of Terbinafine in Dosage Forms and Plasma

Abstract

A newly developed micellar liquid chromatographic analysis technique was utilized for the determination of Terbinafine HCl (TRH). A 150 mm × 4.6 mm i.d., Shim-pack Cyanopropyl-bonded stationary phase was used for analysis. A mixture of 0.15 M sodium dodecyl sulphate (SDS), 0.3% triethylamine(TEA), 10% n-propanol all prepared in 0.02 M orthophosphoric acid was the mobile phase. The pH of the mobile phase was adjusted to 5.5 and pumped at a flow rate of 1 mL/min. The column temperature was set at 45°C. A fluorescence detection of (TRH) at 336 nm emission λ after excitation at 236 nm. Chlorzoxazone (CLZ) was used as an internal standard (IS). The method was linear over the range of 0.4-8.0 μg/mL. The limit of detection (LOD) and limit of quantification (LOQ) were 0.07 μg/ mL and 0.22 μg/mL, respectively. The method was further applied for analysis of the studied drug in its tablet, spray, cream and gel formulations. Not only this, but extending the application of the method for determination of terbinafine hydrochloride in spiked human plasma without prior extraction. Statistical analysis through comparison of the data obtained by the proposed and comparison methods, showed good accuracy and precision of the proposed method.