毛细管气相色谱法测定盐酸倍他洛尔中的残留溶剂  

Capillary Gas Chromatographic Determination of Residual Solvents in Betaxolol Hydrochloride

作　　者：张建业[1] 可钰[1] 阎学斌[1] 刘宏民[1] 

机构地区：[1]郑州大学新药研究开发中心

出　　处：《郑州大学学报（理学版）》2005年第2期98-100,共3页Journal of Zhengzhou University:Natural Science Edition

基　　金：国家自然科学基金项目;编号20272054

摘　　要：采用毛细管气相色谱法对盐酸倍他洛尔原料药中丙酮、异丙醇及甲苯残留量进行测定.色谱柱为HP-1石英毛细管柱(0.53mm×30m,1.5μm),柱温采用程序升温,载气为氮气,流速为2.0mL/min,在该条件下,丙酮、异丙醇在10～90mg/L,甲苯在1.78～16.02mg/L的质量浓度范围内峰面积与质量浓度成线性关系,相关系数分别为0.9997,0.9997,0.9996.加样回收率、精密度、溶液稳定性的试验结果均可满足三者残留量分析的要求.A capillary gas chromatographic method for determination of the residual amounts of acetone,isopropanol and toluene in betaxolol hydrochloride is reported.The analytical column is HP-1 capillary quartz column(0.53 mm×30 m,1.5 μm).The column temperature is programmed.The carrier gas is nitrogen and its flow rate is 2.0 mL/min.With the analytical conditions listed above,the linear range(the peak area vs.the mass concentration) of acetone and isopropanol is both from 10 to 90 mg/L,and of toluene is from 1.78 to 16.02 mg/L,and the relative coefficients are 0.999 7,0.999 7 and 0.999 6,respectively.The recoveries,precisions and solution stability are all fit for the determination of acetone,isopropanol and toluene as residual solvents.

关 键 词：毛细管气相色谱法 残留溶剂 盐酸 测定 石英毛细管柱 残留量分析 溶液稳定性 程序升温 线性关系 质量浓度 浓度范围 相关系数 试验结果 异丙醇 原料药 色谱柱 min 峰面积 回收率 精密度 可满足 丙酮 甲苯 柱温 

分 类 号：O657.71[理学—分析化学] TS227[理学—化学]