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

Ranitidine hydrochloride
C13H22N4O3S·HCl 350.87
1,1-Ethenediamine, N-[2-[[5-[(dimethylamino) methyl]-2-furanyl]-methyl] thio] ethyl]-N¢-methyl-2-nitro-, monohydrochloride.
N-[2-[[5-[(Dimethylamino) methyl]-2-furanyl]methyl]thio]ethyl]-N¢-methyl-2-nitro-1,1-ethenediamine, hydrochloride [66357-59-3 ].
Ranitidine Hydrochloride nwere ihe na-erughị 97.5 pasent na ọ bụghị karịa 102.0 pasent nke C13H22N4O3S·HCl, gbakọọ na akpọnwụwo ndabere.
Nkwakọ ngwaahịa na nchekwa - Chekwaa n'ime akpa siri ike, enweghị ọkụ.
Ụkpụrụ ntụaka USP <11>-
USP Ranitidine Hydrochloride RS
Ngwakọta Mkpebi USP Ranitidine RS
Ọ bụ ngwakọta nke ranitidine hydrochloride na ihe adịghị ọcha anọ metụtara ya: ranitidine-N-oxide, ranitidine complex nitroacetamide, ranitidine diamine hemifumarate, na 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 mgbagwoju nitroacetamide: N-[2-[[[5-[(dimethylamino) methyl]furan-2-yl] methyl] sulphanyl] ethyl] -2-nitroacetamide.
Ranitidine diamine hemifumarate (ihe metụtara A): 5-[[(2-aminoethyl) thio] methyl] -N, N-dimethyl-2-furanmethanamine, hemifumarate nnu.
Ranitidine amino mmanya hemifumarate: [5-[(dimethylamino)methyl]furan-2-yl] methanol.
njirimara-
A: Infrared absorption <197M>.
B: Mmetụta Ultraviolet <197U>-
Ngwọta: 10 μg kwa ml.
Ọkara: mmiri.
Absorptivities na 229 nm na 315 nm, gbakọọ na nke a mịrị amị, adịghị iche karịa 3.0%.
C: Ngwọta ya na-emezu ihe achọrọ maka ule maka Chloride <191>.
pH <791>: n'etiti 4.5 na 6.0, na ngwọta (1 na 100).
Ọnwụ na ihicha <731>-Kọchaa ya na agụụ na 60 maka awa 3: ọ na-efunahụ karịa 0.75% nke ibu ya.
Ihe fọdụrụ na mgbanye <281>: ọ bụghị karịa 0.1%.
Chromatographic ịdị ọcha-
Diluent, usoro mkpanaaka, ngwọta mkpebi, yana sistemụ Chromatographic-Gaa n'ihu dị ka enyere ya na Assay.
Ọkọlọtọ ngwọta- Kwadebe dị ka akwadoro maka nkwadebe ọkọlọtọ na Assay.
Ngwọta nwale- Kwadebe dị ka akwadoro maka nkwadebe Assay na Assay.
Usoro-iche iche, gbanye nha nha nha nha (ihe dịka 10 µL) nke ọkọlọtọ ọkọlọtọ na ngwọta Nnwale n'ime chromatograph, dekọọ chromatograms, wee chọpụta ọnụ ọgụgụ ranitidine na ọnụ ọgụgụ kachasị elu n'ihi adịghị ọcha na ngwaahịa mmebi nke edepụtara na tebụl dị n'okpuru.
Aha Oge Njide Oyiyi
Ranitidine dị mfe nitroacetamide1 0.14
Ranitidine oxime2 0.21
Amino mmanya Ranitidine 3 0.45
Ranitidine diamine 4 0.57
Ranitidine S-oxide5 0.64
Ranitidine N-oxide6 0.72
Ihe mgbagwoju anya Ranitidine 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-otu oxime.
3 {5-[(Dimethylamino)methyl]furan-2-yl}methanol.
4 5-{[(2-Aminoethyl) thio]methyl}-N, N-dimethyl-2-furanmethanamine (ranitidine metụtara ogige A).
5 N-{2-[({5-[(Dimethylamino)methyl]-2-furanyl}methyl)sulfinyl]ethyl}-N¢-methyl-2-nitro-1,1-ethenediamine (ranitidine metụtara compound C).
6 N,N-Dimethyl(5-{[(2-{[1-(methylamino))-2-nitroethenyl]amino}ethyl)
sulphanyl]methyl}furan-2-yl) methanamin 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 metụtara compound B).
Tulee nzaghachi maka ọnụ ọgụgụ ndị bụ isi, wee gbakọọ pasent nke adịghị ọcha ọ bụla na mpaghara Ranitidine Hydrochloride nke usoro a were were:
100CV/W (ri / rS)
nke C bụ ntinye uche, na mg kwa ml, nke ranitidine hydrochloride na ngwọta Standard;V bụ olu, na mL, nke ngwọta ule;W bụ arọ, na mg, nke Ranitidine Hydrochloride ewepụtara iji dozie ngwọta Nnwale;ri bụ nzaghachi kachasị elu maka adịghị ọcha ọ bụla enwetara site na ngwọta ule;na rS bụ nzaghachi ọnụ ọgụgụ kachasị elu nke ranitidine nwetara site na Standard solution: ọ bụghị ihe karịrị 0.3% nke ranitidine bis-compound ka a chọtara, ọ bụghị ihe karịrị 0.1% nke adịghị ọcha ọ bụla ọzọ, ma ọ bụghị ihe karịrị 0.5% nke ihe adịghị ọcha. .Ọkwa mkpesa maka adịghị ọcha bụ 0.05%.
Nyocha -
Ihe nchekwa Phosphate-Ebe ihe dị ka 1900 ml mmiri n'ime flask volumetric 2.0-L, tinye nke ọma 6.8 ml nke phosphoric acid, ma gwakọta.Tinye nke ọma 8.6 ml nke 50% sodium hydroxide ngwọta, ma jiri mmiri na-atụgharị na olu.Ọ bụrụ na ọ dị mkpa, dozie ya na 50% sodium hydroxide solution ma ọ bụ phosphoric acid na pH nke 7.1, na nyo.
Ngwọta A- Kwadebe ngwakọta nke ihe nchekwa Phosphate na acetonitrile (98:2).
Ngwọta B- Kwadebe ngwakọta nke ihe nchekwa Phosphate na acetonitrile (78:22).
Usoro mkpanaaka-Jiri ngwakọta agbanwe agbanwe nke Ngwọta A na Ngwọta B dịka akwadoro maka sistemụ Chromatographic.Mee mgbanwe ọ bụrụ na ọ dị mkpa (lee Dabara Sistemu n'okpuru Chromatography 621).
Ngwọta Diluent-Jiri A.
Nkwadebe ọkọlọtọ-Kwụsa USP Ranitidine Hydrochloride RS nke a tụrụ n'ụzọ ziri ezi n'ime diluent iji nweta ngwọta nwere njiri mara nke ihe dịka 0.125 mg nke ranitidine hydrochloride kwa ml.
Ngwọta mkpebi - Nyefee ihe dịka 1.3 mg nke USP Ranitidine Resolution Mixture RS ka ọ bụrụ flask volumetric 10-mL, wee gbazee ma gbanye ya na Diluent ka ọ bụrụ olu.[ndeba ama-USP Ranitidine Resolution Mixture RS nwere ranitidine hydrochloride na adịghị ọcha anọ metụtara ya: ranitidine amino alcohol hemifumarate, ranitidine diamine hemifumarate, ranitidine N-oxide, na ranitidine complex nitroacetamide.]
Nkwadebe nyocha- Nyefee ihe dịka 25 mg nke Ranitidine Hydrochloride, nke a tụrụ nke ọma, gaa na flask volumetric 200-mL.Gbanyụọ ma gbanye ya na Diluent ka ọ bụrụ olu, ma gwakọta ya.
Usoro Chromatographic (lee Chromatography <621>) -Chromatograph nke mmiri mmiri na-eji ihe nchọpụta 230-nm na kọlụm 4.6-mm × 10-cm nwere 3.5-µm nkwakọ L1 nke kwụsiri ike site na pH 1 ruo 12. Ọnụ ọgụgụ na-asọpụta bụ. ihe dị ka 1.5 ml kwa nkeji.A na-edobe okpomọkụ kọlụm na 35. A na-ahazi chromatograph dị ka ndị a.
Oge (nkeji) Ngwọta A (%) Ngwọta B (%) Elution
0-10 100®0 0®100 gradient linear
10-15 0 100 isocratic
15-16 0®100 100®0 gradient linear
16-20 100 0 re-equilibrationChromatograph the Resolution solution, na chọpụta ọnụ ọgụgụ kasị elu na-eji tebụl nke adịghị ọcha na mmebi ngwaahịa (dị n'elu): mkpebi, R, n'etiti ọnụ ọgụgụ kasị elu maka ranitidine N-oxide na ranitidine mgbagwoju nitroacetamide adịghị ala karịa. 1.5.Chromatograph the Standard nkwadebe, na dekọọ nzaghachi kacha elu dị ka akwadoro maka Usoro: ihe ngbanwe ọkọlọtọ maka injections oyiri abụghị ihe karịrị 1.0%.
Usoro-iche iche nha nha nha (ihe dị ka 10 µL) nke nkwadebe ọkọlọtọ na nkwadebe Assay n'ime chromatograph, dekọọ chromatograms, wee tụọ mpaghara maka ọnụ ọgụgụ ndị bụ isi.Gbakọọ pasent C13H22N4O3S·HCl n'ime akụkụ Ranitidine Hydrochloride nke usoro a were were:
100 (CS / CU) (rU / rS)
nke CS na CU bụ ihe nchịkọta, na mg kwa mL, nke ranitidine hydrochloride na nkwadebe Standard na nkwadebe Assay, n'otu n'otu;na rU na rS bụ nzaghachi kacha elu enwetara site na nkwadebe Assay na nkwado ọkọlọtọ, n'otu n'otu.