A Stability Indicating High Performance Liquid Chromatographic Assay (HPLC) for the Determination of Terbinafine Hydrochloride in Bulk Drug Substance

A simple, accurate, and stability-indicating reversed phase high-performance liquid chromatography (HPLC) method was developed and validated for the quantitative determination of terbinafine hydrochloride in bulk drug substance. Chromatographic separation was performed using C18 column and an isocratic mobile phase consisting of methanol and acetonitrile (60:40, v/v) with (0.15% triethylamine and 0.15% phosphoric acid) at a flow rate of 0.4 ml/min. The eluents were monitored by UV photodioide array detector at wavelength of 224nm.

The method was statistically validated for linearity, specificity, accuracy, precision, limit of detection, limit of quantification and robustness. The stability – indicating nature of the method had been proved by subjecting terbinafine hydrochloride to acidic hydrolysis, basic hydrolysis, oxidation, thermal and photo degradation. Degradation products resulted from the stress studies did not interfere with the detection of the drug and thus the assay is stabilityindicating.