Étude de la solubilité et de la stabilité de la terbinafine hydrochloride

Abstract

rbinafine hydrochloride is a systemic antifungal drug used for the treatment of skin infections. It comes in three dosage forms: tablet, cream and topical spray solution. Goals The aim of this work is to develop and then validate an isocratic, stability indicating HPLC for the determination of terbinafine hydrochloride as well as the study of its solubility and its stability in aqueous medium as a function of pH. Methods The HPLC method uses a C18 (150 * 4.6) mm column; 5µm with a flow rate of 1ml / min, UV detection at 283 nm and a mobile phase which consists of a mixture of (buffer pH 7.5 / methanol / acetonitrile): (15: 50: 35) .v / v / v . The stability and the solubility of terbinafine hydrochloride were studied in aqueous medium at pH ranging from 2 to 9. The determination of the solubility at 20 ° C. was carried out by the shake-flask method. Stability was made over a period of 28 days at room temperature. Results The HPLC method developed is found to be specific, repeatable (RSD = 0.15%), accurate (recovery = 99.5%), precise (RSD = 1.7%), linear (R2 = 0.999) and robust. The molecule showed instability at very acidic pH values and satisfactory stability from pH=3. It is poorly soluble in an aqueous medium at pH ranging from 2 to 9 with a slight decrease depending on the increase in pH. It is approximately 6.7 ± 0.9 mg / ml. Conclusion The results obtained are useful during formulation tests