顶空气相色谱法测定盐酸普鲁卡因中的残留溶剂

Determination of Residual Organic Solvents in Procaine Hydrochloride by Headspace Gas Chromatography

目的:建立盐酸普鲁卡因中乙醇、丙酮残留量的测定方法。方法:采用顶空气相色谱法,以水为溶解介质,色谱柱为DB-1301石英毛细管柱,柱温80℃,检测器为FID,检测器温度为250℃,进样口温度为150℃,结果:乙醇、丙酮的线性范围分别为0.025～2.0 mg·ml^(-1)(r=0.999 9)和0.025～2.0 mg·ml^(-1)(r=0.999 9);平均回收率分别为99.6%(RSD=0.6%)和99.5%(RSD=1.1%);定量限分别为4.79μg·ml^(-1)和3.01μg·ml^(-1)。结论:方法简单、准确,可用于盐酸普鲁卡因中乙醇和丙酮残留量的测定。

Objective： To establish a method for determination the residual organic solvents-alcohol and acetone in procaine hydro- chloirde. Method： The residual organic solvents were determined by headspace gas chroniatography on DB-1301 capillary column with FID detector,the samples were dissolved in water, the column temperature was 80℃, the detector temperature was 250 ~C, the inlet temperature was 150 ℃. Result： The linear ranges of alcohol and acetone were 0. 025-2. 0 mg.ml=1 （r =0. 999 9） and 0. 025-2.0 mg . ml - 1 （ r = 0. 999 9 ）, the average recoveries were 99. 6% （ RSD = 0.6% ） and 99. 5 % （ RSD = 1.1% ） respectively, the quantitative limits were 4. 79 μg.ml-1 and 3.01 μg.m1-1. Conclusion： The method is simple and accurate,it can be used for determination the re- sidual organic solvents in procaine hydrochloirde.