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泮托拉唑钠中有机溶剂残留量的毛细管GC测定
Determination of Residual Organic Solvents in Pantoprazole Sodium by Capillary GC
【摘要】 建立了顶空毛细管GC法同时测定泮托拉唑钠原药中甲醇、乙醇、丙酮、二氯甲烷、乙酸乙酯和甲苯6种有机溶剂的残留量。以DMF-水(8∶2)为溶剂,采用DM-1大口径毛细管柱,FID检测器。6种有机溶剂分别在24~1200、40~2000、40~2000、5~240、40~2000、7~356μg/ml范围内线性关系良好,平均回收率为98.6%~100.3%,RSD为1.3%~2.1%;检测限分别为0.3、0.27、0.19、0.19、0.16、0.8μg/ml。
【Abstract】 A static headspace capillary GC method was established for simultaneous determination of six residual organic solvents in pantoprazole sodium. A DM-1 capillary column was used with DMF-H2O(8∶2) as the solvent and FID was used as detector. The calibration curves of six solvents were linear in the concentration ranges of 24 -1 200,40 -2 000,40 -2 000,5 -240,40 -2 000,and 7 -356 μg/ml,respectively. The average recoveries were 98.6% -100.3% with RSDs of 1.3% -2.1%. Their detection limits were 0.3,0.27,0.19,0.19,0.16,0.8 μg/ml,respectively.
【Key words】 pantoprazole sodium; residual organic solvent; headspace injection; capillary GC; determination;
- 【文献出处】 中国医药工业杂志 ,Chinese Journal of Pharmaceuticals , 编辑部邮箱 ,2009年04期
- 【分类号】R927
- 【下载频次】187