摘要
目的为控制马来酸依那普利原料药的质量,建立项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0．20HD 5～0．8021mg/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。
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 acetfc 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. 199 9 -0. 799 7 mg/mL （ r=0. 998 9） and the linear range of alcohol was 0. 2005-0. 802 1 mg/mL （r=0. 999 9）. 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 enalapfil maleate.
出处
《中国药业》
CAS
2007年第2期34-35,共2页
China Pharmaceuticals
