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

Ranitidine hydrochloride
C13H22N4O3S·HCl 350.87
1,1-Ethenediamine, N- [[[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 ha e na ka tlase ho karolo ea 97.5 lekholong mme e seng ho feta karolo ea 102.0 lekholong ea C13H22N4O3S·HCl, e baloang motheong o omisitsoeng.
Ho paka le ho boloka-Ho boloka ka har'a lijana tse thata, tse sa keneleng khanya.
USP Reference standards <11>-
USP Ranitidine Hydrochloride RS
USP Ranitidine Resolution Mixture RS
Ke motsoako oa ranitidine hydrochloride le litšila tse 'nè tse amanang le tsona: ranitidine-N-oxide, ranitidine complex nitroacetamide, ranitidine diamine hemifumarate, le 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 e rarahaneng nitroacetamide: N- [[[5-[(dimethylamino) methyl]furan-2-yl]methyl]sulphanyl]ethyl] -2-nitroacetamide.
Ranitidine diamine hemifumarate (e amanang le motsoako A): 5-[[(2-aminoethyl) thio]methyl]-N, N-dimethyl-2-furanmethanamine, letsoai la hemifumarate.
Ranitidine amino alcohol hemifumarate: [5--[(dimethylamino) methyl]furan-2-yl]methanol.
Boitsebiso-
A: Infrared Absorption <197M>.
B: Ho Monyeha ha Ultraviolet <197U>-
Tharollo: 10 µg ka mL.
Hare: metsi.
Li-Absorptivities ho 229 nm le 315 nm, tse baloang motheong o omisitsoeng, ha li fapane ho feta 3.0%.
C: Tharollo ea eona e kopana le litlhoko tsa liteko tsa Chloride <191>.
pH <791>: pakeng tsa 4.5 le 6.0, ka tharollo (1 ho 100).
Tahlehelo ka ho omisa <731> -E omise ka vacuum ka 60 bakeng sa lihora tse 3: ha e lahlehe ho feta 0.75% ea boima ba eona.
Masala a ho khantša <281>: eseng ho feta 0.1%.
Bohloeki ba Chromatographic-
Diluent, Mobile phase, Resolution solution, le Chromatographic system-Tsoela pele joalokaha ho laetsoe ho Assay.
Tharollo e tloahelehileng-Itokise joalo ka ha ho laetsoe bakeng sa boitokiso bo tloaelehileng ho Assay.
Tharollo ea liteko-Lokisetsa joalo ka ha ho laetsoe bakeng sa boitokisetso ba Assay ho Assay.
Ts'ebetso-Ka karohano kenya meqolo e lekanang (e ka bang 10 µL) ea Tharollo e Tloaelehileng le Tharollo ea Teko ka har'a chromatograph, rekota li-chromatogram, 'me u khetholle tlhoro ea ranitidine le litlhoro ka lebaka la litšila le lihlahisoa tsa ho senyeha tse thathamisitsoeng tafoleng e ka tlase.
Bolela Nako e Batlang ea ho Boloka
Ranitidine e bonolo nitroacetamide1 0.14
Ranitidine oxime2 0.21
Ranitidine amino joala 3 0.45
Ranitidine diamine4 0.57
Ranitidine S-oxide5 0.64
Ranitidine N-oxide6 0.72
Ranitidine e rarahaneng 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-oxime e le 'ngoe.
3 {5-[(Dimethylamino)methyl]furan-2-yl}methanol.
4 5-{[(2-Aminoethyl)thio]methyl}-N,N-dimethyl-2-furanmethanamine (motsoako o amanang le ranitidine A).
5 N-{2-[({5-[(Dimethylamino)methyl]-2-furanyl}methyl)sulfinyl]ethyl}-N¢-methyl-2-nitro-1,1-ethenediamine (motsoako o amanang le ranitidine 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 (motsoako o amanang le ranitidine B).
Lekanya likarabo tsa litlhōrō tse kholo, 'me u bale liperesente tsa litšila ka bong karolong ea Ranitidine Hydrochloride e nkiloeng ka foromo:
100CV/W(ri/rS)
moo C e leng mahloriso, ka mg ka mL, ea ranitidine hydrochloride ka tharollo e tloaelehileng;V ke molumo, ka mL, oa tharollo ea Tlhahlobo;W ke boima ba 'mele, ka mg, ea Ranitidine Hydrochloride e nkiloeng ho lokisetsa tharollo ea Tlhahlobo;ri ke tlhōrō ea karabelo bakeng sa litšila ka 'ngoe tse fumanoang ho tsoa ho Tharollo ea Tlhahlobo;'me rS ke karabelo ea tlhōrō ea ranitidine e fumanoang ho tsoa tharollong ea Standard: ha ho 0.3% ea ranitidine bis-compound e fumanoang, ha ho na ho feta 0.1% ea litšila tse ling tse fumanoang,' me ha ho 0.5% ea litšila tsohle tse fumanoang. .Boemo ba tlaleho ea litšila ke 0.05%.
Tlhahlobo-
Phosphate buffer-Beha hoo e ka bang 1900 mL ea metsi ka har'a botlolo ea volumetric ea 2.0-L, ka nepo eketsa 6.8 mL ea phosphoric acid, 'me u kopanye.Eketsa ka nepo 8.6 mL ea 50% sodium hydroxide solution, 'me u hlapolle ka metsi ho ea bophahamong.Haeba ho hlokahala, fetola ka 50% sodium hydroxide solution kapa phosphoric acid ho pH ea 7.1, 'me sefa.
Tharollo A-Lokisetsa motsoako oa Phosphate buffer le acetonitrile (98:2).
Tharollo B-Lokisetsa motsoako oa Phosphate buffer le acetonitrile (78:22).
Mobile phase-Sebelisa metsoako e feto-fetohang ea Tharollo A le Tharollo B joalokaha e laetsoe bakeng sa tsamaiso ea Chromatographic.Etsa litokiso ha ho hlokahala (sheba Tšebeliso ea Sistimi tlas'a Chromatography 621).
Diluent-Sebelisa Tharollo A.
Tlhophiso e tloahelehileng-Hlakola tekanyo e lekantsoeng e nepahetseng ea USP Ranitidine Hydrochloride RS ho Diluent ho fumana tharollo e nang le motsoako o tsejoang oa hoo e ka bang 0.125 mg ea ranitidine hydrochloride ka mL.
Resolution solution-Fetisetsa hoo e ka bang 1.3 mg ea USP Ranitidine Resolution Mixture RS ho 10-mL volumetric flask, 'me e qhibilihe le ho hlapolla ka Diluent ho bophahamo ba modumo.[hlokomela-USP Ranitidine Resolution Mixture RS e na le ranitidine hydrochloride le litšila tse 'nè tse amanang le tsona: ranitidine amino alcohol hemifumarate, ranitidine diamine hemifumarate, ranitidine N-oxide, le ranitidine complex nitroacetamide.]
Boitokisetso ba tlhahlobo-Fetisetsa hoo e ka bang 25 mg ea Ranitidine Hydrochloride, e lekantsoeng ka nepo, ho botlolo ea volumetric ea 200-mL.Qhibiliha 'me u hlapolle ka Diluent ho bophahamo ba modumo, ebe o kopanya.
Chromatographic system (sheba Chromatography <621>)-Mokelikeli oa chromatograph o na le mochine oa 230-nm le kholomo ea 4.6-mm × 10-cm e nang le 3.5-µm packing L1 e tsitsitseng ho tloha pH 1 ho ea ho 12. Sekhahla sa ho phalla ke hoo e ka bang 1.5 mL ka motsotso.Mocheso oa kholomo o bolokiloe ho 35. Chromatograph e hlophisitsoeng ka tsela e latelang.
Nako (metsotso) Tharollo A (%) Tharollo B (%) Elution
0-10 100®0 0®100 mothapo o lekanang
10-15 0 100 isocratic
15-16 0®100 100®0 lekhalo la mola
16-20 100 0 re-equilibrationChromatograph Tharollo ea Tharollo, 'me u khetholle litlhōrō tse sebelisang tafole ea litšila le lihlahisoa tse silafetseng (tse fumanoang ka holimo): qeto, R, pakeng tsa litlhōrō tsa ranitidine N-oxide le ranitidine complex nitroacetamide ha e tlase ho feta. 1.5.Chromatograph ea Boitokisetso ba Maemo, 'me u tlalehe likarabelo tse phahameng joalo ka ha li laetsoe bakeng sa Ts'ebetso: kheloha e lekanyelitsoeng bakeng sa liente tse ikatisang ha e fete 1.0%.
Ts'ebetso-Ka karohano kenya li-volume tse lekanang (tse ka bang 10 µL) tsa Tokisetso e Tloaelehileng le boitokisetso ba Assay ho chromatograph, rekota li-chromatogram, 'me u lekanye libaka tsa litlhoro tse kholo.Bala peresente ea C13H22N4O3S·HCl karolong ea Ranitidine Hydrochloride e nkiloeng ka foromo:
100(CS / CU)(rU / rS)
moo CS le CU li leng teng, ka mg ka mL, ea ranitidine hydrochloride ka ho lokisetsa Standard le ho lokisetsa Assay, ka ho latellana;'me rU le rS ke likarabelo tse phahameng tse fumanoeng ho tsoa ho Tokisetso ea Assay le Tokiso ea Maemo, ka ho latellana.