摘要
目的:建立左旋棉酚原料药中残留溶剂四氢呋喃和乙醚的测定方法。方法:采用毛细管气相色谱法,程序升温,外标法计算残留溶剂的含量。结果:建立的色谱方法对待测溶剂具有良好的分离度。四氢呋喃在7.10～1056.60mg·L-1,乙醚在2.00～300.30mg·L-1范围内呈现良好的线性关系(四氢呋喃R2=0.9998,乙醚R2=0.9998)。平均回收率分别为98.69%和98.58%。测得3批左旋棉酚原料药中乙醚和四氢呋喃残留量均符合中国药典的要求。结论:建立的方法灵敏、准确而简便,可适用于左旋棉酚原料药中有机溶剂残留量的测定。
OBJECTIVE To establish a method for the determination of residual organic solvents in （ - ）-gossypol raw material by the use of GC. METHODS An Agilent 19091J 413 HP5 5% Phenyl Methyl Siloxane（30. 0 μm× 320 μm,0. 25 μm） capillary column was used with nitrogen as carrier gas and FID detector, programmed temperature and direct injection shunt was used, the residual solvents were calculated by external standard method. RESULTS Tetrahydrofunan in the range of 7. 10 - 1 056.6（1 mg·L^-1 had a good linear relationship （R^2 = 0. 999 8） and Diethyl Ether in the range of 2. 00 - 300. 30mg· L ^-1 al so had a good linear relationship （R^2 = 0. 999 8）. The average recovery was 98. 69% and 98. 58%. Three batches of samples were analyzed by the method. None of residual organic solvent exceeded limit. CONCLUSION The method is proved to be sensitive, accurate and simple, it is suitable to analysis the residual organic solvents in （ - ）-gossypol.
出处
《中国医院药学杂志》
CAS
CSCD
北大核心
2010年第15期1288-1291,共4页
Chinese Journal of Hospital Pharmacy
基金
教育部重点科技研究项目(编号:205185)
新疆生产建设兵团博士资金项目(编号:2009JC14)
石河子大学高层次人才科研启动资金专项(编号:RCZX200762)
关键词
气相色谱法
左旋棉酚
残留溶剂
gas chromatography
（ - ） gossypol
residual solvents
