呋喃妥因肠溶片中邻苯二甲酸酯类物质的定性分析及定量检测

目的建立呋喃妥因肠溶片中邻苯二甲酸酯类物质定性分析及定量检测的方法。方法采用气质联用色谱法进行定性分析。采用高效液相色谱法对筛查出的5种邻苯二甲酸酯类物质进行定量检测,色谱柱为Phenomenex C18色谱柱(250mm×4.6mm,5μm),以乙腈-水(90∶10)为流动相,流速1.0mL·min-1,检测波长为224nm,柱温为30℃。结果对用气质联用色谱法筛查出的5种邻苯二甲酸酯类物质,建立了高效液相色谱法测定方法。DMP,DEP,DBP,DPP和BBP质量浓度在1²50μg·mL-1范围内线性关系良好,回收率在87%250μg·mL-1范围内线性关系良好,回收率在87%¹07%范围内。结论该法简便、快速、准确,可用于呋喃妥因肠溶片中邻苯二甲酸酯类化合物的定性分析及定量检测。

Qualitative and quantitative analysis of phthalates in Nitrofurantoin Enteric Tablets

Objective To establish a method to identify and determine phthalates in Nitrofurantoin Enteric Tablets .Methods GC-MS was used to identify phthalates ,and HPLC was used to determine the content of phthalates .The quantitative analysis were performed on a Phenomenex C18 column（250 mm × 4 .6 mm ,5μm） ,the mobile phase consisted of acetonitrile-water （90∶10） with a flow rate 1 .0 mL · min-1 ,and the detection wavelength was at 224 nm .Results HPLC method was used to determine phthalates screened by GC-MS .The linear ranges of DMP ,DEP ,DBP ,DPP ,BBP were 1-250 μg · mL -1 .The sample recoveries of DMP , DEP ,DBP ,DPP ,BBP were in the ranges of 87%-107% .Conclusion The method has been proved to be simple and accurate .It has been applied in the qualitative and quantitative analysis of phthalates in Nitrofurantoin Enteric Tablets .