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时间:2020-04-22
《反相高效液相色谱法测定愈创维林那敏片的含量和含量均匀度-论文.pdf》由会员上传分享,免费在线阅读,更多相关内容在应用文档-天天文库。
1、·药物鉴定·中I荔2014年9月5日第23卷第17期DrugIdenfificotionChinaPharmaceuticalsVo1.23,No.17,September5,2014反相高效液相色谱法测定愈创维林那敏片的含量和含量均匀度拳刘慧颖,陈默,孙宽(1.辽宁省食品药品检验所,辽宁沈阳110023;2.内蒙古自治区满洲里市口岸食品药品检验所,内蒙古满洲里021400)摘要:目的建立快速测定愈创维林那敏片含量和含量均匀度的反相高效液相色谱(RP—HPLC)法。方法对样品处理方法、色谱柱和流动相等因素进行优化,确定选用TechMateCt
2、8色谱柱(250mm×4.6mm,5txm),甲醇一磷酸调pH至3.0的1.5%三乙胺溶液(50:50)为流动相,紫外检测波长为224nm。结果愈创甘油醚、马来酸氯苯那敏和枸橼酸喷托维林的质量浓度线性范围分别为20.74~38.50~g/mL(r=0.9989),20.78—38.60~g/mL(r=0.9988)和104.30~193.70~g/mL(r:0.9983),平均回收率分别为98.75%,99.06%,99.53%,RSD分别为1.20%,1.20%,1.50%。结论该方法色谱分离效果好,可靠、简便、准确,可用于愈创维林那敏片的
3、药品质量控制与快速检验。关键词:高效液相色谱法;含量测定;含量均匀度;愈创甘油醚;马来酸氯苯那敏;枸橼酸喷托维林;愈创维林那敏片中图分类号:11927.2;11974.1文献标识码:A文章编号:1006—4931(2014)17—0046—03DeterminationofContentandContentUniformityinYuchuangWeilinNaminTabletsbyRP—HPLCMethodLiuHuiying,ChenMo,SunKuanfJ.LiaoningProvincialInstituteforFoodandDr
4、ugControl,Shenyang,Liaoning,China110023;2.ManzhouliMunicipalPortInstituteforFoodandDrugControl,Maazhouli,Neimenggu,China021400)Abstract:0bjecfiveToestablishaRP—HPLCmethodforrapidlydeterminingthecontentandthecontentuniformityinYuchuangWeilinNaminTablets.MethodsThefactorsofsa
5、mpleprocessingmethod,chromatographiccolumnandmobilephasewereoptimized.TheTechMateCl8column(250mmx4.6mm,5m)wasselected,themobilephasewasmethanol一1.5%triethylamineaqueoussolution(adjustingpHto3.0withphosphoricacid)(50:50)andthedetectionwavelengthwassetat224nm.ResultsThelinear
6、rangeswere2O.74—38.50~g/mL(r=0.9989)forguaifenesin20.78—38.60~g/mL(r:0.9988)forchlorphenaminemaicateand104.30—193.70txg/mL(r=0.9983)forpentoxywerinecitrate.respectively.Themeanrecoveryratesofthethreecompoundswere98.75%99.06%and99.53%,respectively,RSD1.20%,1.20%,1.50%respect
7、ively.ConclusionTheestablishedmethodachievesquitegoodchromatographicseparation,andisreliable,simpleandaccurateforquantification,andcanbeusedforthequalitycontrolandrapidde—tectionofYuchuangWeilinNaminTablets.Keywords:HPLC;contentdetermination;contentuniformity;guaifenesin;ch
8、lorphenaminemalcate;pentoxywerinecitrate;YuchuangWeilinNaminTablets愈创维林那敏片为镇咳祛痰类非处
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