|
|
|
| Determination of Residual Organic Solvents in Ethyl Cellulose by GC |
| WANG Wen-tong1,LI Man2 |
| 1.Hebei Huibang Medical Science and Techbology Corporation Ltd.,Shijiazhuang 050035, China; 2.Reaearch Laboratory of CSPC Ouyi Pharmaceutical Corporation Ltd.,Shijiazhuang 050051,China |
|
|
|
|
Abstract The method for detection of residual solvents in ethyl cellulose was established which is headspace gas chromatography( GC ) , using the column of DB-624, FID as detector and nitrogen as the carrier gas, calculation of the contents of residual solvents by external standard method. The results show the linear relationship is good in the concentration range of the test. For the ethanol, the correlation coefficient is 0.999 8, the recovery is 99.1% and RSD is 2.2% and the limited of detection ( LOD ) is 5.04 μg/mL; for ethyl ether, the correlation coefficient is 0.9999 9, the recovery is 97.7%, RSD is 1.8% and the LOD is 0.51 μg/mL; for the toluene，the correlation coefficient is 0.999 8, the recovery is 98.1%, the RSD is 1.6% and the LOD is 1.81 μg/mL. The method has good specificity, repeatability and high sensitivity, and can be used for determination of residual solvents in ethyl cellulose.
|
|
|
|
|
|
| [ 1 ] 邵自强，王飞俊. 纤维素醚[ M ]. 北京：化学工业出版社，2007：93-105，260-264．
[ 2 ] Melzer E, Kreuter J, Daniels R. Ethylcellulose：a new type of emul-sion stabilizer[ J ]. European Journal of Pharmaceutics and Biopharmaceutics，2003，56（1 ）：23-27．
[ 3 ] 李 春，孙 悦. 顶空气相色谱法测定乙基纤维素中有机溶剂残留量[ J ]. 中国药业，2010，19（8 ）：48-49.
[ 4 ] 国家药典委员会. 中华人民共和国药典（2010版）[ S ]. 二部.北京：中国医药科技出版社，2010：1 177.
[ 5 ] Indiran PS, Irina Russell, JamesA, et al.Sustained release theophylline tablets by direct compression Part1：formulation and in vitro testing[ J ]. Int J Pharm, 1998（2）：164-170.
[ 6 ] Fassihi AR and Parker MS. Controlled drug release from a compressed heterogeneous polymeric matrix: kinetics of release[ J ]. Drug Dev Ind Pharm.1986（12）：1 649.
[ 7 ] 王 晋，史建栋，陈 鹏，等. 乙基纤维素固体分散物对药物释放度影响因素的研究[ J ]. 中国药学杂志, 2000， 35（3 ）166-168.
[ 8 ] Umprayn K, Chitropas P, Amarekajorn S, et al .Development of terbu-taline sulfate sustained-release coated pellets [ J ]. Drug Dev Ind Pharm，1999，25（4 ）：477-491.
[ 9 ] 张 烜，张钧寿，刘国杰，等. 双氯芬酸钠乙基纤维水性分散体包衣片影响药物释放因素的研究[ J ]. 中国新药杂志，1999，8（4 ）：235-237.
[10] 李药兰，黄才欢，岑颖洲，等. 茶多芬缓释微囊的制备研究[ J ]. 中药材，2000，35（5 ）：281-283. |
|
|
|
