CAJ | 학술논문

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PhenomenexC18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1～250μg·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。
목적：건립부남타인장용편중린분이갑산지류물질정성분석급정량검측적방법。방법채용기질련용색보법진행정성분석。채용고효액상색보법대사사출적5충린분이갑산지류물질진행정량검측，색보주위PhenomenexC18색보주（250mm×4．6mm，5μm），이을정-수（90∶10）위류동상，류속1．0mL·min-1，검측파장위224nm，주온위30℃。결과대용기질련용색보법사사출적5충린분이갑산지류물질，건립료고효액상색보법측정방법。DMP，DEP，DBP，DPP화BBP질량농도재1～250μg·mL-1범위내선성관계량호，회수솔재87％～107％범위내。결론해법간편、쾌속、준학，가용우부남타인장용편중린분이갑산지류화합물적정성분석급정량검측。
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 .