HPLC 法测定葡萄糖注射液中5-羟甲基糠醛的含量.pdf

HPLC法测定葡萄糖注射液中5-羟甲基糠醛的含量-,null哈药集团三精制药股份有限公司Knull1null:建立葡萄糖注射液中5-羟甲基糠醛的含量测定方法bZE:高效液相色谱法,采用Diamonsil(钻石)C18(250null4null6mm,5nullm)色谱柱；0null05mol/L磷酸二氢钾-乙腈(80:20)为流动相；柱温30；流速1null0ml!min-1；检测波长284nmbT:在0null4201nullg/ml25null204nullg/ml浓度范围内5-羟甲基糠醛的峰面积和浓度具有良好的线性关系,R=1null00000；平均回收率为100null27%,RSD(%)=0null55%b:本方法准确,可靠,重复性好,可作为葡萄糖注射液质量控制方法b1oM:葡萄糖注射液；5-羟甲基糠醛；高效液相色谱法ms|:R927null2nullnullnullnullDSM:AnullnullnullnullcI|:1006-2882(2011)01-021-03Determinationof5-HydroxymethyfurfuralinGlucoseInjectionbyHPLCYaoHuimin,etalSanjingPharmaceuticalConull,Ltd,HarbinPharmnullGroupAbstract:Objective:Toestablishanassayofdeterminationof5-HydroxymethyfurfuralinGlucoseInjectionbyHPLCnullMethods:HPLCwascarriedoutonaDiamonsilC18(250null4null6mm,5nullm)column；Themobilephaseconsistedofpotassinullumdihydrogenphosphate-acetonitrile(80:20)withtheflowrateof1null0ml!min-1nullThecolumnremainedat30andthedenulltectionwavelengthwasat284nmnullResults:Thestandardcurvewasingoodlinearityintherangeof0null4201nullg/ml25null204nullg/m,lR=1null00000fordeterminationofitsrelatedsubstancesnullTheaveragerecoveryratewas100null27%,RSD=0null55%null6100null250null62960null59001null2086798null157104null820null65830null82601null4516696null058104null450null65590null82601null4525796null459105null220null66080null82601null4553396null19nullnull_ZE,9lqb(lq97null04%,VNsZEbV8nulllkTk|k|mgks(mg)vFmgL=mglq(%)(lq(%)RSD(%)199null890null18980null10720null2897793null262100null190null19040null10720null2899092null82398null760null18760null10720null2872792null98499null860null18970null18760null3626292null17599null410null18890null18760null3631292null8794null482null966100null250null19050null18760null3625491null717104null820null19920null24120null4357498null078104null450null19850null24120null4356598null329105null220null19990null24120null4365098null09nullnull_ZE,9lqb(lq94null48%,VNsZEb2null7nullkcZE!kAsY0a2a4a8a16lH,sRSD=0null069%,4eRSD=0null28%,VzbV9nullkTHW(lH)s(SRSD(%)070372727036494703481703300486null060null069870310116702546V10nullkTHW(lH)4e(SRSD(%)034816623505074350379349790982null470null288350344163495543nullZEI4|sa4e?rrsbeLaaVbVI4|ebID1nullSE0nullS0(B)Snull:,2005:69-70nulll:2010-09-15!21!CD0HeilongjiangMedicineJournalVolnull24Nonull12011Conclusion:Themethodisaccurate,reliableandreproducibleandcanbeusedforthequalitycontrolofGlucoseInjectionnullKeywords:GlucoseInjection；5-Hydroxymethyfurfura；lHPLCnullnull$A5-JD,i_ZE,8=/bID,ErAME5-JDcb1nullNk0Agilent1100SeriesrAMN,Agilent1100Series,-Vn；_b$A(|:080123,?:10m:l5g,gr),5-JDv(kY,YVs1Ec99null78%,_),YB,=_KsBb2nullHq:Diamonsil(GF)C18(250null4null6mm,5nullm)M:0null05mol/L=_K:Y(80:20)null:1null0ml/min_o:284nmnull:303nullk|$5g,100ml,FMidY,vHq,|20nulllAMN,:cm,4$5-JD=HW,TV=HW,sz,Mb4nullL#S|5-JDv4null21mg,25ml,FMidY,(；|5ml100ml,FMdY,(,Tv!A,vHq,sY|v!A1null,l2null,l5null,l10null,l20null,l40null,l60nulll(MvAisY0null4201nullg/m,l0null8401nullg/m,l2null100nullg/m,l4null201nullg/m,l8null401nullg/m,l16null803nullg/m,l25null204nullg/ml)AMN,:cmbiUS,:US,LB,TnV1bV1nullL1TI|i(nullg/ml)10null420180null35620null8401163null31332null100412null60744null201825null15158null4011657null046616null8033311null422725null2044965null687nullnullBZ:A=197null11266*C-1null36016R=1null00000TV,5-JD0null4201nullg/ml25null204nullg/mliS=L1zb5nullk|L/v!A5ml10ml,FMdY,(,vHq,|20nulllAMN,:cm,6Q,TnV2bV2nullTQ1820null3792820null0153820null3894820null4795821null0656820null045(820null465RSD(%)0null05nullnullTV,6QMSl1%,zb6nullKHq/,.110:1KKb|1m,l10ml,FMdY,(,|A1m,l100ml,FMdY,(,|20nulllAMN,:cm,TV,S/N10,SwLi0null012nullg/mlbyNKlK0null012nullg/mlb7nullk|6z,vHq,sY|20nulllAMN,:cm,SE9,cbTnV3bV3nullTI|1546null8032547null1133547null2284547null2545547null4736546null439(547null052RSD(%)0null07nullnullTV,kMSl1%,zb8nulllqk8null1nullF-i|5m,l10ml,FMd!22!CD0HeilongjiangMedicineJournalVolnull24Nonull12011生血康口服液黄芪甲苷含量测定方法学研究fnull1,f12,B31null哈药集团三精制药股份有限公司；2null三精艾富西药业有限公司；3null三精英美药业有限公司Knull1null:建立高效液相色谱法测定生血康口服液的含量bZE:采用迪马(钻石)C18(250mmnull4null6mm,5nullm)色谱柱,乙腈-水(35-65),流速1null0ml/min,蒸发光散射检测器bT:黄芪甲苷与其它杂质能达到有效分离,在0null03021mg/ml0null19206mg/ml范围内,浓度同峰面积呈良好的线形关系,r=0null999698,仪器精密度RSD为2null81%,方法的重复性RSD为3null78%b:该方法简便a准确a可行b可用于生血康口服液的质量控制b1oM:高效液相色谱法；黄芪甲苷；含量测定ms|:R927null2nullnullnullnullDSM:AnullnullnullnullcI|:1006-2882(2011)01-023-02DeterminationofPotassiumDehydroandrograpolideSuccinateInjectionbyHPLCZhangJie,etalY,(,H3z,sY|20nulllAMN,:cmbSEL/SwLibTnV4bV4nullF-iTI|i(nullg/ml)11null25021null24931null253(1null2518null2nullF|L/5-JDv!A1null5m,l2m,l2null5ml(sYM5-JD12null6015nullg,16null802nullg,21null0025nullg)3z,sY10ml,6sY|5m,lsY10ml,MdY,(,vHq,sY|20nulllAMN,:cmbSEL/SwLi,9lqbTnV5bV5nulllqTF-(a,nullg)F(b,nullg)(b-a,nullg)lq(%)(lq(%)RSD(%)12null6012null5125null1412null63100null2412null6012null5125null1912null68100null6312null6012null5125null2212null71100null8716null8012null5129null4416null93100null7716null8012null5129null3916null88100null4816null8012null5129null3216null81100null0621null0012null5133null4120null9099null5221null0012null5133null3620null8599null2921null0012null5133null6321null12100null57100null270null55nullnullTV,5-JDlq(98%102%W,ZEVL,S=b9nullYVZE,TVZEa,L1z,?c1pbyN$A5-JD_ZE/:vrAME(c#D)bHqdakEAoAA4,0null05mol/L=_K-Y(80:20)M；_o284nmb5-JD92000bE|20nulllAMN,:cm,6|5-JDva,FMid1mlc4nullgA,EbSE9,k5-JDcV12nullg/mlb10null)10null1nullM4:KkM0null05mol/L=_K-Y