Determination of residual solvents in ranolazine by headspace gas chromatography / 南方医科大学学报

ABSTRACT

<p><b>OBJECTIVE</b>To determine the contents of the residual solvents, methanol, ethanol, toluene, dichloromethane and dioxane in ranolazine raw material.</p><p><b>METHODS</b>Headspace gas chromatography was used to analyze the residual solvents quantitatively. Samples were analyzed on an HP-INNOWAX column with column temperature at 45 degrees Celsius; using water as solvent.</p><p><b>RESULTS</b>Five residual solvents were completely separated. The liner range and recoveries were satisfied. RSD of precision and accuracy was less than 8% with average recoveries between 87.1% and 105.6%.</p><p><b>CONCLUSION</b>The method could be used for the quality control of ranolazine raw material.</p>