顶空气相色谱法测定马来酸依那普利中残留溶剂含量

目的为控制马来酸依那普利原料药的质量，建立顶空气相色谱法测定马来酸依那普利中残留溶剂乙酸乙酯、乙醇的含量。方法以N，N-二甲基甲酰胺为溶剂制备对照品及供试品溶液，以聚乙二醇毛细管柱为分离柱，氮气为载气，采用程序升温方式，FID检测器。结果乙酸乙酯在0.1999—0.7997mg／mL、乙醇在0．2005～0.8021mg／mL范围内与相应成分峰面积线性关系良好（r分别为0．9989和0.9999），平均回收率分别为101％和100％，重复进样峰面积RSD分别为1．6％和1．5％（n=5）。结论顶空气相色谱法专属性强，简便准确，可用于马来酸依那普利残留溶剂的控制。

Determination of Acetic Ether and Alcohol in Enalapril Maleate by Headspace Gas Chromatography

Objective To establish a method for the determination of residual acetic ether and alcohol in enalapril maleate by headspace gas chromatography.Methods Temperature programming and Poly-G capillary column were used.The headspace thermostatting tempature and time on the determination of acetic ether and alcohol were studied.The solvent of the preparation of the test sloution was N,N- dimethylformamide.Results The linear range of acetic ether was 0.1999-0.7997mg/mL (r=0.998 9) and the linear range of alcohol was 0.2005-0.802 1 mg/mL (r=0.9999).The average recovery rates of acetic ether and alcohol were 101% and 100%,with RSD was 1.5% and 1.6% (n=5),respectively.Conclusion This method is simple,fast,accurate,and can be used to determine residual acetic ether and alcohol in enalapril maleate.