[Determination of residual solvents in ranolazine by headspace gas chromatography].

OBJECTIVE: To determine the contents of the residual solvents, methanol, ethanol, toluene, dichloromethane and dioxane in ranolazine raw material. METHODS: 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. RESULTS: 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%. CONCLUSION: The method could be used for the quality control of ranolazine raw material.