Method Development and Validation for Estimation of Etifoxine in Capsule Dosage Form by Using RP-HPLC/UV

Abstract

A RP-HPLC/UV method was developed and validated to quantify the etifoxine in capsule dosage form. The chromatographic separation was carried out using a Hypersil ODS C18 column (250×4.6 mm, 5 μm) with a mobile phase consisting of an ammonium acetate buffer: acetonitrile in a volumetric ratio of 40:60%. The UV wavelength chosen for detection was at 255 nm. The flow rate was set at 1 ml/min. The retention time for etifoxine was determined to be 2.074 min.  Linearity was detected within the concentration range of 7.5-45 μg/mL for etifoxine. The approach has been confirmed to be linear, accurate, precise, robust, and has established limits of detection and quantitation. The established procedure was uncomplicated, cost-effective, and suitable for the routine analysis of etifoxine in capsule dosage form.