Development of Validated of Stability Indicating RP-HPCL Assay Method for Terbinafine Hydrochloride

Abstract

A stability indicating assay method was developed and validated for determination of Terbinafine hydrochloride in bulk drug. The separation was accomplished on an Inertsil C-8 (150 mm × 4.6 mm; particle size 5 μm) column under isocratic mode. The mobile phase was phosphate buffer pH 7: ACN: Methanol (18.75:32.5:48.75, v/v/v). The flow rate was 1.2 ml min-1 and a PDA detector set at 280 nm was used for detection. The proposed method was validated in terms of accuracy, precision, reproducibility according to ICH guidelines. Forced degradation of Terbinafine hydrochloride was also carried out under thermal, photo, acidic, alkaline and peroxide conditions. It was concluded that Terbinafine hydrochloride degrades in oxidative and photolysis condition. The method is simple and accurate as it is able to separate the degradation products from the API. Thus the method can be used for routine analysis of the Terbinafine hydrochloride.