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顶空气相色谱法测定盐酸普鲁卡因中的残留溶剂
引用本文:宋更申,张西如,庞文哲. 顶空气相色谱法测定盐酸普鲁卡因中的残留溶剂[J]. 中国药师, 2010, 13(4): 526-527
作者姓名:宋更申  张西如  庞文哲
作者单位:河北省药品检验所,石家庄,050011
摘    要: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一1301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0.025~2.0nag·ml-1(r=0.9999)和0.025—2.0mg·ml-1(r=0.9999);平均回收率分别为99.6%(RSD=0.6%)和99.5%(RSO: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。

关 键 词:硕空气相色谱法  盐酸普鲁卡因  残留溶剂  乙醇  丙酮

Determination of Residual Organic Solvents in Procaine Hydrochloride by Headspace Gas Chromatography
Song Gengshen,Zhang Xiru,Pang Wenzhe. Determination of Residual Organic Solvents in Procaine Hydrochloride by Headspace Gas Chromatography[J]. China Pharmacist, 2010, 13(4): 526-527
Authors:Song Gengshen  Zhang Xiru  Pang Wenzhe
Affiliation:( Hebei Institute for Drug Control, Shijiazhuang 050011, China)
Abstract: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.
Keywords:Headspace gas chromatography  Procaine hydrochloirde  Residual organic solvents  Alcohol  Acetone
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