Itraconazole CAS 84625-61-6 Assay 98.5 ~ 101.5%

Itraconazole nwere ihe na-erughị 98.5 pasent na ọ bụghị ihe karịrị 101.5 pasent nke C35H38Cl2N8O4, gbakọọ na akpọnwụwo ndabere.
Nkwakọ ngwaahịa na nchekwa - Chekwaa n'ime akpa siri ike, na-enweghị ọkụ, ma chekwaa n'ime ụlọ okpomọkụ.
Ụkpụrụ ntụaka USP <11>-
USP Itraconazole RS
USP Miconazole RS
njirimara-
A: Infrared absorption <197K>.
Ntugharị nkuku <781A>: n'etiti -0.10° na +0.10°, tụrụ na 20°
Ngwọta ule: 100 mg kwa ml, na methylene chloride
Oke agbaze <741>: n'etiti 166° na 170°
Ọnwụ na ihicha <731>-Kọ ihe dị ka 1 g na 105 Celsius maka awa 4: ọ na-efunahụ karịa 0.5% nke ibu ya.
Ihe fọdụrụ na mgbanye <281>: ọ bụghị karịa 0.1%, kpebisiri ike na 1.0 g.
Ngwakọta ndị emetụtara-
Ngwọta A: 0.08 M tetrabutylammonium hydrogen sulfate.
Ngwọta B: acetonitrile
Diluent- Kwadebe ngwakọta nke methanol na tetrahydrofuran (1: 1).
Ọkọlọtọ ngwọta-Kwụsa n'ụzọ ziri ezi nke USP Itraconazole RS na diluent, nzọụkwụ ma ọ bụrụ na ọ dị mkpa y, iji nweta ngwọta na-enwe a maara n'ihe dị ka 0.05 mg kwa ml.
Ngwọta mkpebi-Kwụsa ọnụọgụ USP Itraconazole RS kwesịrị ekwesị na USP Miconazole na RS na Diluent iji nweta ngwọta ebe amaara ọkwa dị ihe dịka 0.05 mg kwa ml.
Ngwọta nwale-Kwụsa itraconazole n'ụzọ ziri ezi n'ime Diluent iji nweta ngwọta nke nwere mkpokọta amara nke ihe dịka 10 mg kwa ml.
Usoro Chromatographic (lee Chromatography <621>) -Kromatograph mmiri mmiri nwere ihe nchọpụta 225-nm yana kọlụm 4.6mm × 10-cm nke nwere 3- μm mbukota L1.Onu ogugu a bu ihe dika 1.5 ml kwa nkeji.A na-edobe okpomoku kọlụm na 30 Celsius.A na-ahazi chromatograph dị ka ndị a
Ngwọta oge A Solution B
(nkeji) (%) (%) Elu
0–20 80→50 20→50 gradient ahịrị
20–25 50 50 isocratic
25-30 80 20 nhazi
[IHE-Hazie kọlụm ahụ ma ọ dịkarịa ala nkeji 30 na acetonitrile na ọnụego erute nke 1.5 ml kwa nkeji wee kwekọọ na mbido eluent mbụ maka opekata mpe 5.]
Chromatograph the Resolution solution, wee dekọọ nzaghachi kacha elu dị ka akwadoro maka Usoro: mkpebi, R, n'etiti miconazole na itraconazole erughị 2.0.
Usoro-iche iche, gbanye nha nha nha nha (ihe dịka 10 µL) nke ihe nfe mmiri, ihe ngwọta ọkọlọtọ na ngwọta nnwale n'ime chromatograph wee dekọọ chromatograms.Gbakọọ pasent nke adịghị ọcha ọ bụla na akụkụ Itraconazole nke usoro a were were:
100 (CS / CU) (rU / rS)
nke CS bụ ntinye uche, na mg kwa mL, nke Itraconazole na ngwọta Standard;CU bụ ntinye uche, na mg kwa ml, nke Itraconazole na ngwọta Nnwale;rU bụ mpaghara kachasị elu maka adịghị ọcha ọ bụla na ngwọta ule;na rS bụ ebe kachasị elu maka Itraconazole na ngwọta Standard: ọ bụghị ihe karịrị 0.5% nke adịghị ọcha ọ bụla akọwapụtara, dị ka egosiri na Tebụl 1, ka achọtara;na ọ bụghị ihe karịrị 1.25% nke mkpokọta adịghị achọta.Eleghara ọnụ ọgụgụ ọ bụla a hụrụ na diluent anya na ọnụ ọgụgụ ọ bụla na-erughị 0.05%.
Tebụl 1
Oke aha nkịtị (%)
4-Methoxy ewepụtara1 0.5
4-Triazolyl isomer2 0.5
Ihe analog nke propyl 30.5
Analog isopropyl 4 0.5
Epimer5 0.5
n-Butyl isomer6 0.5
Didioxolanyl analog 7 0.5
1 2-sk-Butyl-4-{4-[4- (4-methoxyphenyl) piperazin-1-yl] phenyl}-2H-1,2,4-triazol-3(4H) -otu.
2 4-(4-{4-[4-({(2RS,4SR))-2-[(4H-1,2,4-Triazol-4-yl)methyl]-2-(2,4-dichlorofenyl) -1,3-dioxolan-4-yl}methoxy) phenyl] piperazin-1-yl}phenyl)-2-sec-butyl-2H-1,2,4-triazol-3(4H) -otu.
3 4- (4-{4-[4-({(2RS,4SR))-2-[(1H-1,2,4-Triazol-1-yl)methyl]-2-(2,4-dichlorofenyl) -1,3-dioxolan-4-yl}methoxy) phenyl] piperazin-1-yl} phenyl)-2-propyl-2H-1,2,4-triazol-3(4H) -otu.
4 4- (4-{4-[4-({(2RS,4SR))-2-[(1H-1,2,4-Triazol-1-yl)methyl]-2-(2,4-dichlorofenyl) -1,3-dioxolan-4-yl}methoxy) phenyl] piperazin-1-yl} phenyl -2-isopropyl-2H-1,2,4-triazol-3 (4H) -otu.
5 4- (4-{4-[4-{(2 chelating agents. RS,4RS)-2-[(1H-1,2,4-Triazol-1-yl)methyl]-2-(2, 4-dichlorophenyl)-1,3-dioxolan-4-yl}methoxy) phenyl] piperazin-1-yl} phenyl)-2-sec-butyl-2H-1,2,4-triazol-3(4H) -otu .
6 4-(4-{4-[4-({(2RS,4SR))-2-[(1H-1,2,4-Triazol-1-yl)methyl]-2-(2,4-dichlorofenyl) -1,3-dioxolan-4-yl}methoxy) phenyl] piperazin-1-yl} phenyl)-2-butyl-2H-1,2,4-triazol-3(4H) -otu.
7 4-(4-{4-[4-({(2RS,4SR))-2-[(1H-1,2,4-Triazol-1-yl)methyl]-2-(2,4-dichlorofenyl) -1,3-dioxolan-4-yl}methoxy)phenyl]piperazin-1-yl}phenyl)-2-({(2RS,4SR)-2-[(1H-1,2,4-triazol-1-) yl) methyl] -2- (2,4-dichlorophenyl) -1,3-dioxo-lan-4-yl}methyl -2H-1,2,4-triazol-3 (4H) -otu.
Nyocha -
Diluent- Kwadebe ngwakọta nke methyl ethyl ketone na glacial acetic acid (7: 1).
Usoro - gbazee ihe dị ka 0,3 g nke Itraconazole, nke a tụrụ nke ọma, na 70 ml nke ihe mgbaze.Titrate na 0.1 M kwa chloric acid, na-ekpebi ebe njedebe nwere ike n'ụzọ mmetụta nke abụọ.Otu ml nke 0.1 M kwa chloric acid bụ 35.3 mg nke C 35H38Cl2N8O4.