Ranitidine Hydrochloride CAS 66357-59-3 Assay 97.5~102.0%

I-Ranitidine Hydrochloride
C13H22N4O3S·HCl 350.87
I-1,1-Ethenediamine, N-[2-[[5-[(dimethylamino) methyl]-2-furanyl]-methyl]thio]ethyl]-N¢-methyl-2-nitro-, monohydrochloride.
N-[2-[[[5-[(Dimethylamino)]-2-furanyl]methyl]thio]ethyl]-N¢-methyl-2-nitro-1,1-ethenediamine, i-hydrochloride [66357-59-3) ].
I-Ranitidine Hydrochloride iqulethe ngaphantsi kweepesenti ze-97.5 kwaye ingabi ngaphezu kwe-102.0 ipesenti ye-C13H22N4O3S · HCl, ibalwa kwisiseko esomileyo.
Ukupakishwa kunye nokugcinwa-Londoloza kwimigqomo eqinile, ekwazi ukumelana nokukhanya.
Imigangatho yezalathiso ye-USP <11>-
USP Ranitidine Hydrochloride RS
USP Ranitidine Resolution Mixture RS
Ingumxube we-ranitidine hydrochloride kunye nokungcola okune okuhambelanayo: i-ranitidine-N-oxide, i-ranitidine complex nitroacetamide, i-ranitidine diamine hemifumarate, kunye ne-ranitidine amino alcohol hemifumarate.
I-Ranitidine-N-oxide: N, N-dimethyl[5-[[[2-[[1-(methylamino)-2-nitroethenyl]amino]ethyl]sulphanyl]methyl]furan-2-yl]methanamine N-oxide.
I-Ranitidine i-nitroacetamide eyinkimbinkimbi: N- [[[5-[5-[(dimethylamino)) methyl]furan-2-yl]methyl]sulphanyl]ethyl] -2-nitroacetamide.
I-Ranitidine diamine hemifumarate (i-compound ehambelanayo A): 5-[[(2-aminoethyl) thio]methyl]-N, N-dimethyl-2-furanmethanamine, ityuwa ye-hemifumarate.
I-Ranitidine amino alcohol hemifumarate: [5-[(dimethylamino) methyl]furan-2-yl]methanol.
Isazisi-
A: I-Infrared Absorption <197M>.
B: Ukufunxwa kwe-Ultraviolet <197U>-
Isisombululo: 10 µg ngemL.
Phakathi: amanzi.
I-Absorptivities kwi-229 nm kunye ne-315 nm, ibalwa kwisiseko esomileyo, ayifani ngaphezu kwe-3.0%.
C: Isisombululo sayo siyahlangabezana neemfuno zeemvavanyo zeChloride <191>.
pH <791>: phakathi kwe-4.5 kunye ne-6.0, kwisisombululo (1 kwi-100).
Ilahleko ekumiseni <731>-Yomise kwi-vacuum kwi-60 kwiiyure ze-3: ilahlekelwa ngaphezu kwe-0.75% yobunzima bayo.
Intsalela ekutshisweni <281>: hayi ngaphezulu kwe-0.1%.
Ukucoceka kweChromatographic-
I-Diluent, isigaba se-Mobile, isisombululo seSisombululo, kunye nenkqubo yeChromatographic-Qhubeka njengoko kuyalelwe kwi-Assay.
Isisombululo esisemgangathweni-Lungiselela njengoko kuyalelwe ukulungiswa okuMgangatho kuVavanyo.
Isisombululo sovavanyo-Lungiselela njengoko kuyalelwe ukulungiselela uVavanyo kwi-Assay.
Inkqubo-Ngokwahlukileyo tofa imithamo elinganayo (malunga ne-10 µL) yesisombululo soMgangatho kunye nesisombululo soVavanyo kwichromatograph, urekhode iichromatograms, kwaye uchonge incopho yeranitidine kunye nencochoyi ngenxa yokungcola kunye neemveliso zokuncipha ezidweliswe kwitheyibhile engezantsi.
Igama lokuGcina Ixesha
I-Ranitidine elula i-nitroacetamide1 0.14
Ranitidine oxime2 0.21
Ranitidine amino alcohol3 0.45
Ranitidine diamine4 0.57
I-Ranitidine S-oxide5 0.64
I-Ranitidine N-oxide6 0.72
I-Ranitidine eyinkimbinkimbi ye-nitroacetamide7 0.84
I-Ranitidine formaldehyde idduct8 1.36
Ranitidine bis-compound9 1.75
I-1 N-Methyl-2-nitroacetamide.
2 3-(Methylamino) -5,6-dihydro-2H-1,4-thiazin-2-oxime enye.
I-3 {5 - [(Dimethylamino) methyl]furan-2-yl} imethanol.
4 5-{[(2-Aminoethyl) thio]methyl}-N,N-dimethyl-2-furanmethanamine (ikhompawundi enxulumene ne-ranitidine A).
5 N-{2-[({5-[(Dimethylamino)methyl]-2-furanyl}methyl)sulfinyl]ethyl}-N¢-methyl-2-nitro-1,1-ethenediamine (ikhompawundi enxulumene ne-ranitidine).
6 N,N-Dimethyl(5-{[(2-{[1-(methylamino)-2-nitroethenyl]amino}ethyl)
sulphanyl]methyl}furan-2-yl)methanamine N-oxide.
7 N-{2-[({5-[(Dimethylamino)methyl]furan-2-yl}methyl)sulphanyl]ethyl}-2-nitroacetamide.
8 2,2¢-Methylenebis(N-{2-[({5-[(dimethylamino))methyl]furan-2-yl}methyl)sulphanyl]ethyl}-N¢-methyl-2-nitroethene-1,1- idayimani).
9 N, N¢-bis{2-[({5-[(Dimethylamino)methyl]-2-furanyl}methyl)thio]ethyl}-2-nitro-1,1-ethenediamine (i-ranitidine enxulumene ne-compound B).
Ukulinganisa iimpendulo kwiincopho ezinkulu, kwaye ubale ipesenti yokungcola ngakunye kwisahlulo seRanitidine Hydrochloride esithathwe ngefomula:
100CV/W(ri / rS)
apho i-C igxininise, kwi-mg nge-mL, ye-ranitidine hydrochloride kwisisombululo esiPhakathi;V ngumthamo, kwi-mL, yesisombululo soVavanyo;W ubunzima, ngo-mg, weRanitidine Hydrochloride ethathwe ukulungiselela isisombululo soVavanyo;ri yincopho impendulo yokungcola nganye efunyenwe kwisisombululo Test;kunye ne-rS yimpendulo ephezulu ye-ranitidine efunyenwe kwisisombululo esiPhakathi: akukho ngaphezu kwe-0.3% ye-ranitidine bis-compound efunyenweyo, akukho ngaphezu kwe-0.1% yanoma yimuphi ukungcola okukodwa okufunyenweyo, kwaye akukho ngaphezu kwe-0.5% yokungcola okupheleleyo. .Inqanaba lokunika ingxelo malunga nokungcola yi-0.05%.
Isivavanyi-
I-Phosphate buffer-Beka malunga ne-1900 mL yamanzi kwi-flask ye-volumetric ye-2.0-L, yongeza ngokuchanekileyo i-6.8 mL ye-phosphoric acid, kwaye udibanise.Yongeza ngokuchanekileyo i-8.6 mL ye-50% yesisombululo se-sodium hydroxide, kwaye uhlambulule ngamanzi ukuya kumthamo.Ukuba kuyimfuneko, lungisa kunye ne-50% isisombululo se-sodium hydroxide okanye i-phosphoric acid kwi-pH ye-7.1, kunye nesihlungi.
Isisombululo A-Lungisa umxube we-Phosphate buffer kunye ne-acetonitrile (98: 2).
Isisombululo B-Lungisa umxube we-Phosphate buffer kunye ne-acetonitrile (78:22).
Isigaba esiphathwayo-Sebenzisa imixube eguquguqukayo yeSisombululo A kunye neSisombululo B njengoko kumiselwe inkqubo yeChromatographic.Yenza uhlengahlengiso xa kukho imfuneko (jonga ukufaneleka kweNkqubo phantsi kweChromatography 621).
Diluent-Sebenzisa Isisombululo A.
Ukulungiswa okusemgangathweni-Dibanisa isixa esilinganiswe ngokuchanekileyo se-USP Ranitidine Hydrochloride RS kwi-Diluent ukufumana isisombululo esinoxinzelelo olwaziwayo malunga ne-0.125 mg ye-ranitidine hydrochloride nge-mL nganye.
Isisombululo sesisombululo-Ukudlulisa malunga ne-1.3 mg ye-USP Ranitidine Resolution Mixture RS kwi-flask ye-volumetric ye-10-mL, kwaye udibanise kwaye udibanise nge-Diluent ukuya kwivolumu.[Qaphela-i-USP Ranitidine Resolution Mixture RS iqulethe i-ranitidine hydrochloride kunye nokungcola okune okuhambelanayo: i-ranitidine amino alcohol hemifumarate, i-ranitidine diamine hemifumarate, i-ranitidine N-oxide, kunye ne-ranitidine complex nitroacetamide.]
Ukulungiswa kwe-Assay-Transfer malunga ne-25 mg ye-Ranitidine Hydrochloride, ilinganiswe ngokuchanekileyo, kwi-flask ye-volumetric ye-200-mL.Yinyibilikise kwaye udibanise nge-Diluent ukuya kwivolumu, kwaye udibanise.
Inkqubo yeChromatographic (jonga i-Chromatography <621>)-I-chromatograph yolwelo ixhotyiswe nge-230-nm detector kunye nekholamu ye-4.6-mm × 10-cm equlethe i-3.5-µm yokupakisha i-L1 ezinzileyo ukusuka kwi-pH 1 ukuya kwi-12. malunga ne-1.5 mL ngomzuzu.Ubushushu bekholomu bugcinwa kwi-35. I-chromatograph ihlelwe ngolu hlobo lulandelayo.
Ixesha (imizuzu) Isisombululo A (%) Isisombululo B (%) Uvavanyo
I-0-10 100®0 0®100 i-gradient yomgca
10-15 0 100 isokhrasi
I-15-16 0®100 100®0 i-gradient yomgca
I-16-20 100 0 i-re-equilibrationChromatograph isisombululo seSigqibo, kwaye uchonge iincopho usebenzisa itheyibhile yokungcola kunye neemveliso zokungcola (ezifunyenwe ngasentla): isisombululo, R, phakathi kweencopho ze-ranitidine N-oxide kunye ne-ranitidine eyinkimbinkimbi ye-nitroacetamide ayikho ngaphantsi kwe 1.5.I-Chromatograph Ukulungiswa koMgangatho, kwaye urekhode iimpendulo eziphakamileyo njengoko ziqondiswe kwiNkqubo: ukutenxa komgangatho ohambelanayo we-replicate injection ayikho ngaphezu kwe-1.0%.
Inkqubo-Ngokwahlukileyo tofa imithamo elinganayo (malunga ne-10 µL) yoLungiso oluMgangatho kunye nolungiselelo loVavanyo kwichromatograph, urekhode iichromatograms, kwaye ulinganise iindawo zeencopho ezinkulu.Bala ipesenti yeC13H22N4O3S·HCl kwinxalenye yeRanitidine Hydrochloride ethathwe ngefomula:
100(CS / CU)(rU / rS)
apho i-CS kunye ne-CU yi-concentrations, kwi-mg nge-mL, ye-ranitidine hydrochloride kwi-Standard yokulungiselela kunye nokulungiswa kwe-Assay, ngokulandelanayo;kunye ne-rU kunye ne-rS yincopho yeempendulo ezifunyenwe kulungiselelo loVavanyo kunye nolungiselelo loMgangatho, ngokulandelelanayo.