Determination of residual solvents in ranolazine by headspace gas chromatography.
- Author:
Ya-Lin YE
1
;
Xue-Mei YANG
Author Information
- Publication Type:Journal Article
- MeSH: Acetanilides; analysis; Chromatography, Gas; methods; Drug Contamination; prevention & control; Enzyme Inhibitors; analysis; Ethanol; analysis; Methanol; analysis; Piperazines; analysis; Ranolazine; Reproducibility of Results; Solvents; analysis; Toluene; analysis
- From: Journal of Southern Medical University 2008;28(1):134-135
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVETo determine the contents of the residual solvents, methanol, ethanol, toluene, dichloromethane and dioxane in ranolazine raw material.
METHODSHeadspace 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.
RESULTSFive 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%.
CONCLUSIONThe method could be used for the quality control of ranolazine raw material.
