Ranitidine Hydrochloride CAS 66357-59-3 Mayeso 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 ili ndi osachepera 97.5 peresenti komanso osapitirira 102.0 peresenti ya C13H22N4O3S·HCl, yowerengedwa pa maziko owuma.
Kupaka ndi kusunga-Sungani zotengera zolimba, zosagwira kuwala.
Miyezo yolozera ya USP <11>-
USP Ranitidine Hydrochloride RS
USP Ranitidine Resolution Mixture RS
Ndi chisakanizo cha ranitidine hydrochloride ndi zonyansa zinayi zogwirizana: ranitidine-N-oxide, ranitidine complex nitroacetamide, ranitidine diamine hemifumarate, ndi 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 complex nitroacetamide: N- [[[5-[(dimethylamino)]methyl]furan-2-yl]methyl]sulphanyl]ethyl] -2-nitroacetamide.
Ranitidine diamine hemifumarate (yogwirizana ndi A): 5-[[(2-aminoethyl) thio]methyl]-N,N-dimethyl-2-furanmethanamine, mchere wa hemifumarate.
Ranitidine amino mowa hemifumarate: [5--[(dimethylamino) methyl]furan-2-yl]methanol.
Chizindikiritso-
A: Infuraredi mayamwidwe <197M>.
B: Mayamwidwe a Ultraviolet <197U>-
Yankho: 10 µg pa mL.
Chapakati: madzi.
Ma Absorptivities pa 229 nm ndi 315 nm, owerengedwa pa maziko owuma, samasiyana ndi oposa 3.0%.
C: Yankho lake limakwaniritsa zofunikira za mayeso a Chloride <191>.
pH <791>: pakati pa 4.5 ndi 6.0, mu yankho (1 mu 100).
Kutaya pakuyanika <731> -Iwunitsani mu vacuum pa 60 kwa maola atatu: imataya osapitirira 0,75% ya kulemera kwake.
Zotsalira pakuyatsa <281>: osapitirira 0.1%.
Chromatographic chiyero -
Diluent, Mobile phase, Resolution solution, ndi Chromatographic system-Pitirizani monga momwe mukuyendera mu Assay.
Yankho lokhazikika-Konzekerani monga momwe mwalangizidwira kukonzekera Kwanthawi zonse mu Assay.
Yankho loyesa-Konzekerani monga mwalangizidwa pokonzekera Assay mu Assay.
Dongosolo-Papatula jekeseni ma voliyumu ofanana (pafupifupi 10 µL) a njira Yoyezera ndi Njira Yoyesera mu chromatograph, lembani ma chromatogram, ndi kuzindikira nsonga ya ranitidine ndi nsonga zake chifukwa cha zonyansa ndi zowononga zomwe zalembedwa patebulo pansipa.
Tchulani Nthawi Yachibale Yosunga
Ranitidine yosavuta nitroacetamide1 0.14
Ranitidine oxime2 0.21
Ranitidine amino mowa 3 0.45
Ranitidine diamine4 0.57
Ranitidine S-oxide5 0.64
Ranitidine N-oxide6 0.72
Ranitidine complex nitroacetamide 7 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 imodzi.
3 {5- [(Dimethylamino)methyl]furan-2-yl}methanol.
4 5-{[(2-Aminoethyl)thio]methyl}-N,N-dimethyl-2-furanmethanamine (pawiri yokhudzana ndi ranitidine A).
5 N-{2-[({5-[(Dimethylamino)methyl]-2-furanyl}methyl)sulfinyl]ethyl}-N¢-methyl-2-nitro-1,1-ethenediamine (pawiri yokhudzana ndi 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- diamondi).
9 N,N¢-bis{2-[({5-[(Dimethylamino)methyl]-2-furanyl}methyl)thio]ethyl}-2-nitro-1,1-ethenediamine (pawiri yokhudzana ndi ranitidine).
Yezerani mayankho a nsonga zazikuluzikulu, ndikuwerengera kuchuluka kwa zonyansa zilizonse mu gawo la Ranitidine Hydrochloride lotengedwa ndi chilinganizo:
100CV/W(ri/rS)
momwe C ndi ndende, mu mg pa mL, wa ranitidine hydrochloride mu Standard solution;V ndiye voliyumu, mu ml, ya yankho la Mayeso;W ndi kulemera, mu mg, wa Ranitidine Hydrochloride anatengedwa kukonzekera Mayeso njira;ri ndiye yankho lapamwamba pa zonyansa zilizonse zomwe zimapezedwa kuchokera ku Mayeso;ndi rS ndiye yankho lapamwamba la ranitidine lomwe limapezeka ku Standard solution: osapitirira 0.3% ya ranitidine bis-compound imapezeka, osapitirira 0.1% ya zonyansa zina zilizonse zomwe zimapezeka, ndipo osapitirira 0.5% ya zonyansa zonse zomwe zimapezeka. .Mulingo wa malipoti a zonyansa ndi 0.05%.
Kuyesa-
Phosphate buffer-Ikani pafupifupi 1900 mL yamadzi mu botolo la volumetric 2.0-L, onjezerani molondola 6.8 mL ya phosphoric acid, ndikusakaniza.Onjezani bwino 8.6 mL ya 50% sodium hydroxide solution, ndi kusungunula ndi madzi mpaka kuchuluka.Ngati ndi kotheka, sinthani ndi 50% sodium hydroxide solution kapena phosphoric acid kukhala pH ya 7.1, ndi fyuluta.
Yankho A-Konzani chisakanizo cha Phosphate buffer ndi acetonitrile (98:2).
Yankho B-Konzani chisakanizo cha Phosphate buffer ndi acetonitrile (78:22).
Mobile phase-Gwiritsani ntchito zosakanikirana zosakanikirana za Solution A ndi Solution B monga momwe zalembedwera pa Chromatographic system.Sinthani ngati kuli kofunikira (onani Kukwanira Kwadongosolo pa Chromatography 621).
Diluent-Use Solution A.
Kukonzekera kokhazikika-Sungani muyeso woyezedwa bwino wa USP Ranitidine Hydrochloride RS mu Diluent kuti mupeze yankho lodziwika bwino la 0.125 mg wa ranitidine hydrochloride pa ml.
Resolution solution-Kusamutsa pafupifupi 1.3 mg wa USP Ranitidine Resolution Mixture RS ku 10-mL volumetric botolo, ndi kupasuka ndi kusungunula ndi Diluent kuti voliyumu.[chidziwitso-USP Ranitidine Resolution Mixture RS ili ndi ranitidine hydrochloride ndi zonyansa zinayi zogwirizana: ranitidine amino alcohol hemifumarate, ranitidine diamine hemifumarate, ranitidine N-oxide, ndi ranitidine complex nitroacetamide.]
Kukonzekera kuyesa-Kusamutsa pafupifupi 25 mg wa Ranitidine Hydrochloride, yoyezedwa molondola, ku botolo la volumetric 200-mL.Sungunulani ndi kuchepetsa ndi Diluent kuti voliyumu, ndi kusakaniza.
Chromatographic system (onani Chromatography <621>) - Chromatograph yamadzimadzi imakhala ndi chojambulira cha 230-nm ndi 4.6-mm × 10-cm ndime yokhala ndi 3.5-µm packing L1 yomwe imakhala yokhazikika kuchokera ku pH 1 mpaka 12. pafupifupi 1.5 ml pa mphindi.Kutentha kwapakati kumasungidwa pa 35. Chromatograph imakonzedwa motere.
Nthawi (mphindi) Yankho A (%) Yankho B (%) Kuwunika
0-10 100®0 0®100 mzere wozungulira
10-15 0 100 isocratic
15-16 0®100 100®0 mzere wozungulira
16-20 100 0 re-equilibrationChromatograph njira Resolution, ndi kuzindikira nsonga ntchito tebulo zonyansa ndi zonyansa mankhwala (omwe ali pamwamba): kusamvana, R, pakati pa nsonga za ranitidine N-okusayidi ndi ranitidine zovuta nitroacetamide si osachepera 1.5.Chromatograph the Standard kukonzekera, ndikujambulitsa mayankho apamwamba monga momwe adayankhidwira kachitidwe: kupotokola kofanana kwa jakisoni wobwereza sikudutsa 1.0%.
Kachitidwe-Papatula jekeseni ma voliyumu ofanana (pafupifupi 10 µL) a Kukonzekera Kwanthawi zonse ndi kukonzekera kwa Assay mu chromatograph, lembani ma chromatogram, ndikuyesa madera a nsonga zazikulu.Werengani kuchuluka kwa C13H22N4O3S·HCl mu gawo la Ranitidine Hydrochloride yotengedwa ndi formula:
100(CS / CU)(rU / rS)
momwe CS ndi CU ndizokhazikika, mu mg pa mL, za ranitidine hydrochloride mu Kukonzekera kwa Standard ndi kukonzekera kwa Assay, motsatira;ndi rU ndi rS ndiwo mayankho apamwamba omwe apezedwa kuchokera ku kukonzekera kwa Assay ndi kukonzekera kwa Standard, motsatana.