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目的:建立毛细管气相色谱法测定羟丙基-β-环糊精中乙醇和1,2-丙二醇的残留量的方法。方法:色谱柱为DB-624石英毛细管柱,柱温采用程序升温,FID检测器,检测器温度为250℃,进样口温度为250℃,以二甲亚砜为溶剂。结果:乙醇、1,2-丙二醇的检测浓度的线性范围分别为0.1～5.0 mg·ml~(-1)(r=0.999 9)、0.1～5.0 mg·ml~(-1)(r=0.999 7);平均回收率为分别为99.0%,98.2%,(RSD分别为1.9%,2.2%);最低检出限分别为1.03,0.81 ng;3批样品中2种有机溶剂残留量均符合《中国药典》要求。结论:本方法简单、准确、灵敏度高、重复性好,可用于该药物中有机溶剂残留量的测定。
Objective: To establish a method for the determination of ethanol and 1,2-propanediol in hydroxypropyl-β-cyclodextrin by capillary gas chromatography. Methods: The column was DB-624 quartz capillary column. The column temperature was programmed and the FID detector was used. The temperature of the detector was 250 ℃ and the inlet temperature was 250 ℃. The solvent was dimethyl sulfoxide. Results: The linear ranges of ethanol and 1,2-propanediol were 0.1-5.0 mg · ml -1 (r = 0.999 9), 0.1-5.0 mg · ml -1 (r = 0.999 7). The average recoveries were 99.0% and 98.2%, respectively (RSD 1.9% and 2.2%, respectively). The minimum detection limits were 1.03 and 0.81 ng respectively. The residues of two organic solvents in three batches of samples were in accordance with “ Chinese Pharmacopoeia ”requirement. Conclusion: The method is simple, accurate, sensitive, reproducible and can be used to determine the residual amount of organic solvents in the drug.