<?xml version="1.0" encoding="UTF-8"?><Articles><Article><id>698</id><JournalTitle>METHOD DEVELOPMENT AND VALIDATION FOR THE RESIDUAL  SOLVENT DETERMINATION IN SIMVASTATIN BY GC-FID</JournalTitle><Abstract>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 220Â°C,  Initial column oven temperature was 35Â°C and final column oven temperature 
was  240Â°C  with  5  minute  hold  for  every  rate  of  increase  in  temperature  from  20Â°C  to  40Â°C  per  minute  with  a  detector 
temperature  of  260Â°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</Abstract><Email>drpssvcp@gmail.com</Email><articletype>Research</articletype><volume>6</volume><issue>12</issue><year>2015</year><keyword>Static Headspace Gas chromatography, Flame ionization detector,Residual solvents,Simvastatin</keyword><AUTHORS>Syed Tabraiz Ullah Hussaini,Prathima Srinivas</AUTHORS><afflication>Department of Pharmaceutical Analysis and Quality Assurance, Sri Venkateshwara College of Pharmacy, Hyderabad-500081,  Telangana, India,Department of Pharmaceutical Analysis and Quality Assurance, Sri Venkateshwara College of Pharmacy, Hyderabad-500081,  Telangana, India</afflication></Article></Articles>