New method development and validation for the determination of propafenone HCl in pure drug and its tablet dosage form by RP-HPLC

Abstract

A simple, rapid, accurate, precise, robust and reproducible reverse phase high performance liquid chromatographic method was developed for the determination of Propafenone HCl in pure drug and pharmaceutical dosage form. The quantification was carried out using enable Inertsil ODS-3 Vs column in a binary mode with mobile phase comprising of Acetonitrile: Methanol: Water (90:10) in the ratio of 75:25 %v/v at flow rate 0.7ml/min, detection was carried out at 245 nm using PDA detector with injection volume 20µl, the retention time was found to be 3.438min. The proposed method was validated as per ICH guidelines (Text and Methodology, Q2 (R1), 2005). The method produced a linear response in the concentration range of 1-5µg/ml (R2 0.999). The recovery studies were carried out and found to be within 101%. %RSD was found to be 2%. LOD and LOQ of propafenone HCl for the method were found to be 3.64µg/ml and 11.04µg/ml respectively. The proposed method was statistically evaluated and can be applied for the routine analysis, quality control of raw materials, formulation of different strengths, dissolution studies and bioequivalence studies for the same formulation of propafenone HCl.