Stability-indicating Rp-hplc Method for Analysis of Terbinafine Hydrochloride in Bulk and in Tablet Dosage Form

Terbinafine Hydrochloride (TH) is a new potent antifungal agent. Several HPTLC, non-aqueous voltametric, spectrometric methods, ion-pair RP chromatography and Stability-indicating HPTLC methods have been published till now. The aim of the present study is to develop and validate simple, precise, specific and sensitive stability indicating reversed-phase HPLC (RP-HPLC) method for analysis of Terbinafine Hydrochloride in bulk and in tablet dosage form. Terbinafine hydrochloride was analysed on a Neosphere C18 (250 x 4.6 mm, 5m) with a mobile phase comprising of methanol: 0.5% Triethanolamine. 0.5% Triethanolamine was added to pure methanol to reduce tailing problem. Wavelength of detection was 250 nm. Linear regression study revealed a good linear relationship (R2 = 0.997) between peak area and concentration in the range of 2-12 g/mL. The method was validated for precision, accuracy, specificity and sensitivity (LOD and LOQ). TH was subjected to acidic, basic and neutral (with water) hydrolysis, oxidative, thermal and photodegradation and it was found that drug was degraded in acidic and photolytic condition. Statistical analysis proved that the developed method was accurate, precise, reproducible, specific and sensitive and can be used for routine analysis.