METHOD DEVELOPMENT AND VALIDATION FOR THE RESIDUAL SOLVENT DETERMINATION IN SIMVASTATIN BY GC-FID
A simple and reliable head space gas chromatographic method has been developed for the determination of residual solvent in Simvastatin bulk drug by GC-FID. The proposed method is based on flame ionization detection technique with ZB-624 as stationary phase. This method was developed primarily to detect traces of organic solvents used in the drug synthesis and their interference. The method was then validated by evaluating the specificity, precision, repeatability, linearity, robustness, ruggedness and limits of detection and quantitation. Helium gas was used as carrier gas. The chromatographic conditions set were Injector temperature 220°C, Initial column oven temperature was 35°C and final column oven temperature was 240°C with 5 minute hold for every rate of increase in temperature from 20°C to 40°C per minute with a detector temperature of 260°C,and injection Split ratio1:5. Results proved that the validated method was suitable for determining the residual solvents in simvastatin drug substance (API) for routine analysis