Abstract

METHOD DEVELOPMENT AND VALIDATION OF TRAZODONE HYDROCHLORIDE BY RP- HPLC

J Subba Rao*, R Rambabu, S Vidyadhara, D Jaswanth Ram

Abstract

Simple, accurate, precise and a new reversed-phase high performance liquid chromatographic (RP-HPLC) method has been developed and validated for the estimation of trazodone in pure and dosage forms. The proposed method is based on the separation of the reversed-phase mode using kromasil 100-5C18 Column  250mm × 4.6mm. The optimized mobile phase consisted of acetonitrile: methanol: water in the ratio 40:40:20 v/v, flow rate was set at 1.0 ml/min and UV detection was set at 255 nm. The average retention time was 2.34±0.003mins for trazodone. The method was validated according to ICH guidelines. It was found to be accurate and reproducible. Linearity was obtained in the concentration range of 20-100μg/ml. Percent recovery of sample was found to be 97.65%. The proposed method can be successfully applied in the quality control of bulk and pharmaceutical dosage forms.

Keywords: Trazodone, RP-HPLC, method validation,estimation, methanol and water.