毛细管气相色谱法检测榄香烯原料药的有关物质

目的：建立毛细管气相色谱法（CGC法）检测榄香烯原料药的有关物质。方法：采用DB-WAXetr（60 m×0.32 mm×0.25 μm）毛细管气相色谱柱，柱温为程序升温（起始柱温为80℃，维持5 min，以3℃·min^-1的速率升温至185℃，再以20℃·min^-1的速率升温至230℃，维持60 min），进样口温度230℃，检测器温度230℃，分流比为10：1，进样量1.0 μL。结果：方法的专属性强，β-榄香烯质量浓度在5.003 6~160.12 μg·mL^-1的范围内呈线性（r=1.000 0，n=7），最低检出限为0.87 μg·mL^-1；3批样品的有关物质总量依次为15.4%、15.5%、14.7%。结论：本方法可用于榄香烯原料药的有关物质检测。

Objective: To establish a capillary gas chromatography(CGC)method for determination of related substances in elemene.Methods: The CGC column was DB-WAXetr(60 m×0.32 mm×0.25 μm).The column temperature was programmed to be 80℃ for 5 minutes,and then was raised at a rate of 3℃ per minute to 185℃,and was finally raised at a rate of 20℃ per minute to 230℃ and maintained at 230℃ for 60 minutes.The temperature of the injection port was maintained at 230℃,and that of the flame-ionization detector(FID)was 230℃.The split ratio was 10:1,and the injection volume was 1.0 μL.Results: The method was specific.β-Elemene had a good linear relationship in the range of 5.003 6-160.12 μg·mL^-1(r=1.000 0,n=7)and the lowest limit of detection was 0.87 μg·mL^-1.The total amount of related substances of the three batches of samples was 15.4%,15.5% and 14.7%,respectively.Conclusion: The established method can be used for the determination of related substances in elemene.

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