Propafenone Bioanalytical Method Development And Validation Using RP-UPLC Chromatographic Method Following ICH M10 Guidelines

Abstract

A simple, Accurate, precise method was developed for the estimation of Propafenone in Rabbit plasma was developed and validated. By using protein precipitation technique, the sample preparation was prepared. Chromatogram was run through ACQUITY UPLC HSS C₁₈ Column, 1.8 µm, 2.1 mm X 100 mm, Mobile phase containing Buffer DiSodium Hydrogen Phosphate: Acetonitrile taken in the ratio 70:30 was pumped through column at a flow rate of 0.3ml/min. Buffer used Na₂HPO₄.in this method was buffer. For the separation of Propafenone Internal Standard [IS] used is Vildagliptin. The Temperature was maintained at 30°C. Optimized wavelength selected was 248nm.  Retention time of Propafenone and Internal Standard were found to be 1.273 min and 0.972 min. The standard curve was linear (R2 >0.995) over the concentration range of 15-600 ng/ml. All the analytical validation parameters were determined as per ICH guidelines the bioanalytical method developed approach was selective, robust, and reliable, as accuracy, precision, recovery, and other validation parameters were all within the recommendations' limitations. The peaks produced for the drug of interest and the internal standard were well separated from one another without any plasma interferences, and the peaks were symmetrical with an adequate tailing factor.