Rp-Hplc Method Development and Validation for Simultaneous Estimation of Terbinafine Hydrochloride and Fluticasone Propionate in Their Formulation

Abstract

A Novel, selective and rapid Reversed Phase High Performance Liquid Chromatographic (RPHPLC) method for the analysis of Terbinafine Hydrochloride and Fluticasone Propionate in binary mixture has been developed and validated. The chromatographic system consisted of a Phenomenex Kinetex ® 5µ C18 Size: 150 * 4.6mm column and the separation were achieved by using ambient temperature with a mobile phase containing mobile Phase Methanol: Water (80:20 v/v). The samples were monitored at 238 nm for detection at a flow rate of 1.0 mL/min and the retention time was about 4.90 and 2.05 mins for Terbinafine Hydrochloride and Fluticasone Propionate respectively. The calibration curve was linear over the concentration range 20 - 70 and 1 – 3.5 μg/mL for Terbinafine Hydrochloride and Fluticasone Propionate respectively. The proposed method is accurate in the range of 100.11% - 101.34% recovery and precise (%RSD of intraday variation and %RSD of inter day variation were found to be within the acceptance criteria). Therefore, this method can be used as a more convenient and efficient option for the analysis of Terbinafine Hydrochloride and Fluticasone Propionate in Quality control laboratory