高效液相色谱法同时测定氨咖黄敏胶囊中对乙酰氨基酚和马来酸氯苯那敏的含量.docx

高效液相色谱法同时测定氨咖黄敏胶囊中对乙酰氨基酚和马来酸氯苯那敏的含量[摘要]目的:建立高效液相法同时测定氨咖黄敏胶囊中对乙酰氨基酚和马来酸氯苯那敏含量的方法。方法:采用Shim-PaokCLCODSC18(6.0mm×200mm5μm)色谱柱;流动相:甲醇-0.05mol/L磷酸二氢钾溶液-三乙胺(10∶90∶0.02)(用磷酸调节pH至3.4);检测波长:215nm;流速:1.0ml/min;柱温:30℃。结果:对乙酰氨基酚在0.092～4.604μg范围内与峰面积呈良好的线性关系(r=0.9998)平均回收率为98.40%RSD=1.53%(n=6);马来酸氯苯那敏在4.160～20.800μg范围内与峰面积呈良好的线性关系(r=0.9997)平均回收率为99.24%RSD=1.26%(n=6)。结论:本方法简便、准确、重现性好可用于氨咖黄敏胶囊的质量控制。[关键词]高效液相色谱法;氨咖黄敏胶囊;对乙酰氨基酚;马来酸氯苯那敏;含量测定[中图分类号]R927.2[文献标识码]A[文章编号]1673-7210(2010)02(a)-038-03ContentdeterminationofparacetamolandchlorphenaminemaleateinParacetamolCaffeinAtificialCow-bezoarandChlorphenamineMaleateCapsulesbyHPLCCHENYupuZHANGYiDONGZhipan(JiaozuoInstituteforFoodandDrugControlJiaozuo454000China)[Abstract]Objective:ToestablishamethodforthecontentdeterminationofparacetamolandchlorphenaminemaleateinParacetamolCaffeinAtificialCow-bezoarandChlorphenamineMaleateCapsulesbyHPLC.Methods:TheShim-PaokCLCODSC18(6.0mm×200mm5μm)columnwasused.Themobilephasesconsistedofmethanol0.05mol/Lphosphoricacidandtriethylaminesolution(10∶90∶0.02)(adjustedpHto3.4)theflowratewas1.0ml/minandthedetectionwavelengthwasat215nm.Thecolumntemperaturewas30℃.Results:Thelinearrangesofparacetamolwasat0.092-4.604μg(r=0.9998)theaveragerecoverieswas98.40%withaRSDof1.53%(n=6);thelinearrangesofchlorphenaminemaleatewasat4.160-20.800μg(r=0.9997)theaveragerecoverieswas99.24%withaRSDof1.26%(n=6).Conclusion:ThemethodisfastreliableaccurateandcanbeusedinthequalitycontrolofparacetamolandchlorphenaminemaleateinParacetamolCaffeinAtificialCow-bezoarandChlorphenamineMaleateCapsules.[Keywords]HPLC;ParacetamolCaffeinAtificialCow-bezoarandChlorphenamineMaleateCapsules;Paracetamol;Chlorphenaminemaleate;Contentdetermination氨咖黄敏胶囊为感冒类非处方药品适用于缓解普通感冒及流行性感冒引起的发热、头痛、四肢酸痛、流鼻涕、鼻塞