[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%.


CONCLUSIONS
The method could be used for the quality control of ranolazine raw material.
Ye
Ya-Lin
YL
421 Hospital of PLA, Guangzhou 510318, China. yeyl1978@163.com
Yang
Xue-Mei
XM
D000083:Acetanilides / Q000032:analysis*; D002849:Chromatography, Gas / Q000379:methods; D004340:Drug Contamination / Q000517:prevention & control*; D004791:Enzyme Inhibitors / Q000032:analysis; D000431:Ethanol / Q000032:analysis; D000432:Methanol / Q000032:analysis; D010879:Piperazines / Q000032:analysis*; D000069458:Ranolazine; D015203:Reproducibility of Results; D012997:Solvents / Q000032:analysis*; D014050:Toluene / Q000032:analysis
D000083:Acetanilides; D004791:Enzyme Inhibitors; D010879:Piperazines; D012997:Solvents; D014050:Toluene; D000431:Ethanol; D000069458:Ranolazine; D000432:Methanol