STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR DETERMINATION OF RELATED SUBSTANCE IN VENLAFAXINE HYDROCHLORIDE TABLETSAbstract
Recently, several methods have been developed for the determination of drugs and their impurities products by Reverse Phase-High Performance Liquid chromatography (RP-HPLC). The present paper describes highly specific, linear, precise, rugged, accurate, robust, and stability, indicating the RP-HPLC method for the determination of related substances present in Venlafaxine tablets as per ICH guidelines. Chromatographic separation of impurities at satisfactory level was achieved at the detection wavelength of 235 nm using column Agilent C18 column (4.6 × 150 mm, 5 µ) and a mobile phase of Methanol: Phosphate buffer of pH 6.8 (60:40% v/v), pumped at a flow rate of 1 ml/min. The % recovery of Venlafaxine and Impurity-A was found to be 98.19% and 98.97%, respectively. The % RSD of Venlafaxine and Impurity-A was found to be 0.52 and 0.83, respectively. The proposed method was found to be specific, linear, precise, accurate, robust, stable, and can be successfully used for the determination of related substances.
A. Ajitha * and G. S. Rani
Department of Pharmaceutical Analysis, CMR College of Pharmacy, Kandlakoya, Telangana, India.
17 August 2019
10 January 2020
25 July 2020
01 August 2020