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目的采用气相色谱法检查左炔诺孕酮中的有机溶剂残留量。方法采用顶空进样方式,色谱柱为涂布固定液PEG-20M的极性石英毛细管柱,以氦气为载气,检测器为FID检测器。结果7种溶剂分离良好,最低检出限、线性范围、RSD(%)分别为乙醚2.99ng、49.94～349.58ug/ml(r=0.9990)、RSD=2.60%;丙酮124.3ng、49.72～348.04ug/ml(r=0.9998)、RSD=0.93%;四氢呋喃125.7ng、7.24～50.68ug/ml(r=0.9998)、RSD=1.55%;乙酸乙酯245.7ng、49.14～343.98ug/ml(r=0.9997)、RSD=1.36%;异丙醇766.5ng、51.10～357.70ug/ml(r=0.9996)、RSD=2.11%;乙醇763.5ng、50.90～356.30ug/ml(r=0.9997)、RSD=2.12%;氯仿5240ng、20.96～146.72ug/ml(r=0.9967)、RSD=3.98%。结论本方法准确、简便,可用于检查左炔诺孕酮中的乙醚、丙酮、四氢呋喃、乙酸乙酯、异丙醇和乙醇的含量。
Objective To examine the residual organic solvents in levonorgestrel by gas chromatography. Methods The headspace sampling method was used. The column was a polar quartz capillary column coated with PEG-20M, using helium as the carrier gas and the detector as the FID detector. Results Seven solvents were separated well with the lowest detection limit, linear range and RSD (%) of 2.99 ng and 49.94 ~ 349.58 ug / ml respectively (r = 0.9990), RSD = 2.60%, acetone 124.3 ng and 49.72 ~ 348.04 ug (r = 0.9998), RSD = 1.55%; ethyl acetate 245.7ng, 49.14 ~ 343.98ug / ml (r = 0.9997 ), RSD = 1.36%; Isopropyl alcohol 766.5ng, 51.10 ~ 357.70ug / ml (r = 0.9996), RSD = 2.11%; Ethanol 763.5ng, 50.90 ~ 356.30ug / ml (r = 0.9997) ; Chloroform 5240 ng, 20.96-146.72 ug / ml (r = 0.9967), RSD = 3.98%. Conclusion This method is accurate and simple and can be used to check the contents of diethyl ether, acetone, tetrahydrofuran, ethyl acetate, isopropanol and ethanol in levonorgestrel.