Stability-indicating high-performance thin-layer chromatographic method for analysis of terbinafine in pharmaceutical formulations

Abstract

Summary A new, simple, selective, precise, robust and stability-indicating high-performance thin-layer chromatographic (HPTLC) method has been established for analysis of terbinafine hydrochloride (TH) in the bulk drug and in pharmaceutical formulations. Separation was achieved on aluminium plates precoated with silica gel 60F254, with toluene-ethyl acetate-formic acid 4.5:5.5:0.1 (v/v) as mobile phase. Densitometric analysis was performed at 284 nm. Compact bands of TH were obtained at RF 0.31 ± 0.02. Linearity (r2 = 0.9985), limit of quantification (35 ng per band), recovery (97.6−101.6%), and precision (≤2.19) were satisfactory. The method was applicable for routine analysis and accelerated stability testing of TH in pharmaceutical drug-delivery systems. Because the method can effectively separate the drug from its degradation products, it can be used as a stability-indicating method.