摘要
目的:建立泮托拉唑钠中5种有机溶剂的分离测定方法。方法:采用顶空进样毛细管气相色谱法,FID 检测器,应用 AT-1毛细管柱(30.0m×0.32mm×1μm),载气为氮气,柱温采取程序升温,初始温度40℃,保持4min,再以20℃·min^(-1)的速率升至150℃,保持3min,测定了泮托拉唑钠原料中丙酮、乙醚、二氯甲烷、三氯甲烷、甲苯的残留量。结果:各有机溶剂均能得到有效分离,在所考察的浓度范围内线性关系良好,r 为0.990~0.999,平均回收率为99.3%~105%。结论:本方法灵敏、准确、可靠,可用于泮托拉唑钠中有机溶剂的检测。
Objective:To eastablish a method for determination of five residual solvents in pantoprazole sodium. Methods : Using AT - 1 capillary column ( 30. 0 m × 0. 32 mm × 1 μm), inlets tempreture at 200 ℃, FID detector and programablly tempreture. The initial tempreture was kept at 40 ℃ for 4 min, and the tempreture was raised to 150 ℃ at the rate of 20 ℃·min^-1 and lasted 3 min. Result:Five residual solvents were completely separated and there were good linearies( r =0. 990 -0. 999). The average recovery rate was in the range of 99.3% - 105%. Conclusion:The methods proved to be accurate and sensitive.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2007年第7期1119-1122,共4页
Chinese Journal of Pharmaceutical Analysis
关键词
顶空气相色谱法
泮托拉唑钠
残留溶剂
ICH
headspace capillary gas chromatography
pantoprazole sodium
residual organic solvent
ICH
作者简介
第一作者Tel:(029)85239846;E-mail:xizhifang1@126.com