论文部分内容阅读
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 solvents tetrahydrofuran and diethyl ether in L-gossypol raw material. Methods: The contents of residual solvents were calculated by capillary gas chromatography, programmed temperature and external standard method. Results: The established chromatographic method has good resolution for the solvent to be tested. Tetrahydrofuran showed a good linear relationship between diethyl ether and diethyl ether in the range of 7.10 ~ 1056.60 mg · L-1 and 2.00 ~ 300.30 mg · L-1 (R2 = 0.9998 for tetrahydrofuran and R2 = 0.9998 for diethyl ether). The average recoveries were 98.69% and 98.58% respectively. The residues of diethyl ether and tetrahydrofuran in the three batches of L-gossypol were found to meet the requirements of Chinese Pharmacopoeia. Conclusion: The established method is sensitive, accurate and simple and can be applied to the determination of residual organic solvents in L-gossypol.