Analytical Method Development and Validation of Terbinafine Hydrochloride and Ketoconazole in Bulk and Dosage Form.

Abstract

Abstract For the simultaneous quantification of Terbinafine hydrochloride and Ketoconazole in bulk and tablet dosage form, an RP-HPLC technique has been optimized and validated. The allylamine in the Terbinafine hydrochloride and imidazole in Ketoconazole act as its active constituent and inhibit the ergosterol synthesis which stops the growth of fungal cell. The chromatographic separation was performed on Thermo fisher scientific HPLC having PDA detector by using BDS Hypersil C18 (4.6 X 250mm i.d.) 5µm particle column. Mobile phase comprises of Solution A- 20% of triethylamine buffer in water (pH 6.8 ± 0.05) + 80% of Acetonitrile and methanol (40:60 v/v) and Solution B- Methanol and Acetonitrile (60:40). The proportion of A: B was 50:50 v/v. The pump flow rate was set to be 1.5 ml/min and injection volume was 20 µl. Detection was done using 247nm as the UV wavelength. The technique conformed with all validation requirements as specified by ICH Q2 R1 guidelines and method was found to be linear for Terbinafine hydrochloride and Ketoconazole with correlation coefficient of 0.9998 and 0.9996, respectively. The linearity range for Terbinafine HCl was between 3.13-25 ppm and that for ketoconazole was 1.25-10 ppm. The method was found to be precise, accurate & robust with percent RSD of not more than 2%. So, the suggested method can be used to analyse drug samples on a regular basis.