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

Ranitidine Hydrochloride
C13H22N4O3S·HCl 350.87
1,1-Ethenediamine, N- [[[5-[(dimethylamino)]-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, hydrochloride [66357-59-3) ].
Ranitidine Hydrochloride ine kwete pasi pe97.5 muzana uye kwete kupfuura 102.0 muzana yeC13H22N4O3S · HCl, yakaverengerwa pane yakaomeswa.
Kurongedza uye kuchengetedza-Chengetedza mumidziyo yakasimba, isingagadzike chiedza.
USP Reference mwero <11>-
USP Ranitidine Hydrochloride RS
USP Ranitidine Resolution Mixture RS
Musanganiswa weranitidine hydrochloride uye tsvina ina ine hukama: ranitidine-N-oxide, ranitidine complex nitroacetamide, ranitidine diamine hemifumarate, uye ranitidine amino alcohol hemifumarate.
Ranitidine-N-oxide: N,N-dimethyl[5-[[[2-[[1-(methylamino)-2-nitroethenyl]amino]ethyl]sulphanyl]methyl]furan-2-yl]methanamine N-oxide.
Ranitidine yakaoma nitroacetamide: N--[[[[5--[(dimethylamino)]methyl]furan-2-yl]methyl]sulphanyl]ethyl]-2-nitroacetamide).
Ranitidine diamine hemifumarate (yakabatana musanganiswa A): 5-[[(2-aminoethyl) thio]methyl]-N,N-dimethyl-2-furanmethanamine, hemifumarate munyu.
Ranitidine amino alcohol hemifumarate: [5--[(dimethylamino) methyl]furan-2-yl]methanol.
Identification-
A: Infrared Absorption <197M>.
B: Ultraviolet Absorption <197U>-
Mhinduro: 10 µg pamL.
Pakati: mvura.
Absorptivities pa 229 nm uye 315 nm, yakaverengwa pane yakaomeswa nheyo, haina kusiyana neanopfuura 3.0%.
C: Mhinduro yacho inosangana nezvinodiwa zvekuyedzwa kweChloride <191>.
pH <791>: pakati pe4.5 ne6.0, mune mhinduro (1 mu100).
Kurasikirwa pakuomeswa <731> -Dry it in vacuum pa60 kwemaawa matatu: inorasikirwa kwete kupfuura 0.75% yehuremu hwayo.
Residue pakudzima <281>: kwete kupfuura 0.1%.
Chromatographic kuchena-
Diluent, Mobile phase, Resolution solution, uye Chromatographic system-Enderera mberi sekurairwa muAssay.
Yakajairwa mhinduro-Gadzirira sekurairwa kwayakagadzirirwa kugadzirira muAssay.
Muedzo mhinduro-Gadzirira sekurairwa kweAssay kugadzirira muAssay.
Maitiro-Kuparura jekiseni mavhoriyamu akaenzana (angangoita gumi µL) eiyo Standard mhinduro uye Muedzo mhinduro muchromatograph, rekodha machromatogram, uye ratidza iyo ranitidine peak uye peaks nekuda kwetsvina uye kushatisa zvigadzirwa zvakanyorwa patafura pazasi.
Zita Nguva Yekuchengeta
Ranitidine iri nyore nitroacetamide1 0.14
Ranitidine oxime2 0.21
Ranitidine amino doro3 0.45
Ranitidine diamine4 0.57
Ranitidine S-oxide5 0.64
Ranitidine N-oxide6 0.72
Ranitidine yakaoma nitroacetamide7 0.84
Ranitidine formaldehyde adduct8 1.36
Ranitidine bis-compound9 1.75
1 N-Methyl-2-nitroacetamide.
2 3-(Methylamino) -5,6-dihydro-2H-1,4-thiazin-2-one oxime.
3 {5--[(Dimethylamino)methyl]furan-2-yl}methanol.
4 5-{[(2-Aminoethyl)thio]methyl}-N,N-dimethyl-2-furanmethanamine (ranitidine inoenderana nekomboni A).
5 N-{2--[({5--[(Dimethylamino)methyl]-2-furanyl}methyl)sulfinyl]ethyl}-N¢-methyl-2-nitro-1,1-ethenediamine (ranitidine inoenderana nechikamu C).
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- diamine).
9 N,N¢-bis{2-[({5-[(Dimethylamino)methyl]-2-furanyl}methyl)thio]ethyl}-2-nitro-1,1-ethenediamine (ranitidine inoenderana nekomboni B).
Eresa mhinduro dzenhongonya huru, uye uverenge chikamu chekusachena kwega kwega muchikamu cheRanitidine Hydrochloride inotorwa neformula:
100CV/W(ri/rS)
umo C ndiyo yekuisa, mu mg per mL, yeranitidine hydrochloride muStandard solution;V ndiyo vhoriyamu, mumL, yemubvunzo mhinduro;W ndiyo huremu, mumg, yeRanitidine Hydrochloride yakatorwa kugadzirira mhinduro yeMuedzo;ri ndiyo mhinduro yepamusoro yekusachena kwega kwega kunowanikwa kubva kuMuedzo mhinduro;uye rS ndiyo ranitidine peak mhinduro yakawanikwa kubva kuStandard solution: kwete kupfuura 0.3% ye ranitidine bis-compound inowanikwa, kwete kupfuura 0.1% yeimwe tsvina imwe chete inowanikwa, uye kwete kupfuura 0.5% yetsvina yose inowanikwa. .Chirevo chekuzivisa chetsvina i0.05%.
Kuongorora-
Phosphate buffer-Isa ingangoita 1900 mL yemvura mu2.0-L volumetric flask, nemazvo wedzera 6.8 mL yephosphoric acid, uye sanganisa.Nyatsowedzera 8.6 mL ye50% sodium hydroxide solution, uye dilute nemvura kusvika kuhuwandu.Kana zvichidikanwa, gadzirisa ne50% sodium hydroxide solution kana phosphoric acid kune pH ye7.1, uye sefa.
Mhinduro A-Gadzirira musanganiswa wePhosphate buffer uye acetonitrile (98: 2).
Mhinduro B-Gadzirira musanganiswa wePhosphate buffer uye acetonitrile (78:22).
Nharembozha chikamu-Shandisa akasiyana musanganiswa weSolution A uye Solution B sekurairwa kweChromatographic system.Ita zvigadziriso kana zvichidikanwa (ona System Suitability pasi peChromatography 621).
Diluent-Use Solution A.
Kugadzirira kwakajairwa-Dyisa huwandu hwakayerwa nemazvo hweUSP Ranitidine Hydrochloride RS muDiluent kuti uwane mhinduro ine huwandu hunozivikanwa hunosvika 0.125 mg yeranitidine hydrochloride per mL.
Resolution solution-Shandura inenge 1.3 mg ye USP Ranitidine Resolution Mixture RS kune 10-mL volumetric flask, uye nyunguduka mukati uye inyura neDiluent kusvika kuhuwandu.[chinyorwa-USP Ranitidine Resolution Mixture RS ine ranitidine hydrochloride uye tsvina ina dzine hukama: ranitidine amino alcohol hemifumarate, ranitidine diamine hemifumarate, ranitidine N-oxide, uye ranitidine complex nitroacetamide.]
Kugadzirira kweAssay-Kutamisa nezve 25 mg yeRanitidine Hydrochloride, yakanyatsoyerwa, kune 200-mL volumetric flask.Dissolve in and dilue with Diluent to volume, and mix.
Chromatographic system (ona Chromatography <621>)-Iyo chromatograph yemvura inogadzirwa ne 230-nm detector uye 4.6-mm × 10-cm column ine 3.5-µm packing L1 iyo yakagadzikana kubva pH 1 kusvika 12. Kuyerera kwehuwandu ndiko inenge 1.5 mL paminiti.Iko kupisa kwembiru inochengetwa pa 35. Chromatograph inorongwa sezvinotevera.
Nguva (maminetsi) Solution A (%) Solution B (%) Elution
0-10 100®0 0®100 linear gradient
10-15 0 100 isocratic
15-16 0®100 100®0 linear gradient
16-20 100 0 re-equilibrationChromatograph the Resolution solution, uye cherechedza nhongonya uchishandisa tafura yetsvina uye zvigadzirwa zvinosvibisa (zvinowanikwa pamusoro): chisarudzo, R, pakati pepamusoro peranitidine N-oxide uye ranitidine yakaoma nitroacetamide haisi pasi pe. 1.5.Chromatograph iyo Yakajairwa gadziriro, uye rekodha mhinduro dzepamusoro sekurairwa kweMaitiro: chiyero chakajairwa kutsauswa kwemajekiseni anodzokorora hakusi kudarika 1.0%.
Maitiro-Kuparura jekiseni mavhoriyamu akaenzana (angangoita gumi µL) eChimiro gadziriro uye gadziriro yeAssay muchromatograph, rekodha machromatogram, uye kuyera nzvimbo dzepamusoro-soro.Verenga chikamu cheC13H22N4O3S·HCl muchikamu cheRanitidine Hydrochloride inotorwa neformula:
100(CS / CU)(rU / rS)
umo CS uye CU ndiyo inogadziriswa, mu mg per mL, ye ranitidine hydrochloride muChirongwa chekugadzirira uye kugadzirira kweAssay, maererano;uye rU nerS ndiwo mhinduro dzepamusoro dzakawanikwa kubva mukugadzirira kweAssay uye gadziriro yeStandard, zvichiteerana.