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目的:建立利多卡因贴剂中有机残留溶剂的测定方法。方法:采用毛细管GC法,色谱柱:DB-WAX毛细管柱(30 m×0.25 mm,0.5μm);检测器:FID;载气:氦气;升温程序:起始温度为50℃,维持8 min,继以每min升温50℃的速率升温至250℃,维持15 min;进样口温度:280℃;检测器温度:280℃;分流比:50∶1。结果:丙酮、乙酸乙酯和甲醇均在15.0~600.0μg·ml~(-1)浓度范围内线性关系良好,平均回收率分别为97.4%(RSD=3.2%,n=9)、95.6%(RSD=1.9%,n=9)和112.0%(RSD=4.5%,n=9)。结论:该方法简便、准确,可用于利多卡因贴剂中残留有机溶剂的检测。
Objective: To establish a method for determination of organic residual solvents in lidocaine patch. Methods: The capillary GC method was used. The column was DB-WAX capillary column (30 m × 0.25 mm, 0.5 μm). The detector was FID. The carrier gas was helium. The temperature was raised at 50 ℃ for 8 min , Followed by heating at a rate of 50 ° C per min to 250 ° C for 15 min; inlet temperature: 280 ° C; detector temperature: 280 ° C; split ratio: 50: 1. Results: Acetone, ethyl acetate and methanol showed good linearity in the concentration range of 15.0-600.0μg · ml -1 with the average recoveries of 97.4% (RSD = 3.2%, n = 9) and 95.6% RSD = 1.9%, n = 9) and 112.0% (RSD = 4.5%, n = 9). Conclusion: The method is simple and accurate and can be used for the detection of residual organic solvents in lidocaine patch.