Enalapril Maleate CAS 76095-16-4 Assay 98.0 ~ 102.0% API ịdị ọcha dị elu

Enalapril Maleate
C20H28N2O5·C4H4O4 492.52
l-Proline, 1-[N-[1- (ethoxycarbonyl) -3-phenylpropyl] -l-alanyl] -, (S)-, (Z) -2-butenedioate (1: 1).
1-[N-[(S) -1-Carboxy-3-phenylpropyl] -l-alanyl] -l-proline 1'-ethyl ester, maleate (1: 1) [76095-16-4].
Enalapril Maleate nwere ihe na-erughị 98.0 pasent na ọ bụghị ihe karịrị 102.0 pasent nke C20H28N2O5 · C4H4O4, gbakọọ na akpọnwụwo ndabere.
Nkwakọ ngwaahịa na nchekwa - Chekwaa n'ime akpa emechiri emechi nke ọma, ma chekwaa na okpomọkụ nke ụlọ a na-achịkwa.
Ụkpụrụ ntụaka USP <11>-
USP Enalapril Maleate RS Pịa ka ilele Ọdịdị
njirimara-
A: Infrared absorption <197M>.
B: Oge njide nke nnukwu ọnụ ọgụgụ dị elu na chromatogram nke nkwadebe Assay kwekọrọ na nke ahụ na chromatogram nke nkwadebe Standard, dị ka enwetara na Assay.
Ntụgharị a kapịrị ọnụ <781S>: n'etiti -41.0 na -43.5.
Ngwọta ule: 10 mg kwa ml, na methanol.
Ọnwụ na ihicha <731>-Kọchaa ya na agụụ na nrụgide na-erughị 5 mm nke mercury na 60 maka awa 2: ọ na-efunahụ ihe karịrị 1.0% nke ibu ya.
Ihe fọdụrụ na mgbanye <281>: ọ bụghị karịa 0.2%.
Ọla dị arọ, Usoro II <231>: 0.001%.
Ngwakọta ndị emetụtara-
pH 6.8 Phosphate buffer, pH 2.5 Phosphate buffer, Solution A, Solution B, Mobile phase, Diluent, Enalapril diketopiperazine Solution, Sistemu kwesịrị ekwesị ngwọta, na Chromatographic usoro-Gaa n'ihu dị ka eduzi na Assay.
Ọkọlọtọ ngwọta-Kwụsa n'ụzọ ziri ezi nke USP Enalapril Maleate RS na diluent, na itughari quantitatively, na nzọụkwụ ma ọ bụrụ na ọ dị mkpa, na diluent nweta ngwọta na-enwe a maara mgbanye ihe dị ka 3 µg kwa ml.
Ngwọta nwale-Jiri nkwadebe Assay.
Usoro-iche iche nha nha nha (ihe dịka 50 µL) nke ọkọlọtọ ọkọlọtọ na ngwọta Nnwale n'ime chromatograph, dekọọ chromatogram, wee tụọ nzaghachi mpaghara kacha elu.Gbakọọ pasent nke adịghị ọcha ọ bụla na mpaghara Enalapril Maleate nke usoro a were were:
100 (CS / CT) (ri / rS)
nke CS bụ ntinye uche, na mg kwa ml, nke USP Enalapril Maleate RS na ngwọta ọkọlọtọ;CT bụ ntinye uche, na mg kwa ml, nke Enalapril Maleate na ngwọta ule;ri bụ mpaghara kachasị elu nke adịghị ọcha ọ bụla enwetara site na ngwọta ule;na rS bụ mpaghara kachasị elu nke enalapril enwetara site na ọkọlọtọ ọkọlọtọ: ọ bụghị ihe karịrị 1.0% nke adịghị ọcha ọ bụla nwere oge njigide ihe dị ka 1.10 ka a hụrụ;erughị 0.3% nke adịghị ọcha ọ bụla ọzọ a na-ahụ;na ọ bụghị ihe karịrị 2% nke mkpokọta adịghị achọta.
Nyocha -
pH 6.8 phosphate buffer - gbazee 2.8 g nke monobasic sodium phosphate n'ihe dịka 900 ml mmiri n'ime flask volumetric 1000-mL.Gbanwee ya na ngwọta sodium hydroxide 9M na pH nke ihe dịka 6.8, gbanye mmiri ka ọ bụrụ olu, ma gwakọta ya.
pH 2.5 phosphate buffer - gbazee 2.8 g nke monobasic sodium phosphate n'ihe dịka 900 ml mmiri n'ime flask volumetric 1000-mL.Gbanwee ya na phosphoric acid na pH nke ihe dịka 2.5, gbanye na mmiri ka ọ bụrụ olu, ma gwakọta ya.
Ngwọta A- Kwadebe ngwakọta nke pH 6.8 Phosphate buffer na acetonitrile (19:1).
Ngwọta B- Kwadebe ngwakọta nke acetonitrile na pH 6.8 Phosphate buffer (33:17).
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).
Diluent- Kwadebe ngwakọta nke pH 2.5 Phosphate buffer na acetonitrile (95:5).
Enalapril diketopiperazine ngwọta-jiri nlezianya tinye ihe dị ka 20 mg nke USP Enalapril Maleate RS na beaker 100-mL iji mepụta mkpọmkpọ ebe na ala nke beaker.Tinye beaker n'efere ọkụ n'ihe dị ka ọkara n'ogo kachasị elu nke efere efere ọkụ.Kpoo ihe dị ka nkeji 5 ruo 10 ruo mgbe agbazere ihe siri ike.Ngwa ngwa wepụ beaker na efere ọkụ, ma kwe ka ọ dị jụụ.[ndeba ama-Zere ikpo oke ọkụ iji gbochie mmebi nke okpomọkụ na-ebute, nke ga-eme ka agba aja aja.] Na ihe ndị ahụ jụrụ oyi na beaker tinye 50 ml nke acetonitrile, na sonicate maka nkeji ole na ole ka ọ gbazee.Ihe ngwọta na-enwekarị, na ml nke ọ bụla, n'etiti 0.2 mg na 0.4 mg nke enalapril diketopiperazine.
Nkwadebe ọkọlọtọ-gbarisịa ọnụọgụ USP Enalapril Maleate RS nke a tụrụ n'ụzọ ziri ezi na diluent, wee tụgharịa n'ụzọ ọ bụla, yana n'usoro ma ọ bụrụ na ọ dị mkpa, yana diluent iji nweta ihe ngwọta nwere ọkwa amara nke ihe dịka 0.3 mg kwa ml.
Ngwọta dabara adaba sistemụ-Tinye 1 ml nke Enalapril diketopiperazine ngwọta na akụkụ 50-ml nke nkwadebe ọkọlọtọ, ma gwakọta.
Nkwadebe nyocha- Nyefee ihe dịka 30 mg nke Enalapril Maleate, tụọ ya nke ọma, na flask volumetric 100-mL, gbazee ma gbanye ya na diluent ka ọ bụrụ olu, ma gwakọta ya.
Usoro Chromatographic (lee Chromatography <621>) -Kromatograph mmiri mmiri nwere ihe nchọta 215-nm yana kọlụm 4.1-mm × 15-cm nke nwere nkwakọba L21.Onu ogugu a bu ihe dika 1.5 ml kwa nkeji.A na-edobe okpomoku kọlụm na 70. A na-ahazi chromatograph dị ka ndị a.
Oge (nkeji) Ngwọta A(%) Ngwọta B(%) Elution
0 95 5 nha nhata
0-20 95→40 5→60 gradient ahịrị
20-25 40 60 isocratic
25-26 40→95 60→5 gradient ahịrị
26-30 95 5 isocratic
Chromatograph nke dabara adaba sistemu, wee dekọọ nzaghachi kacha elu dị ka akwadoro maka Usoro: oge ​​njide ikwu ihe dị ka 1.0 maka enalapril yana 2.1 maka enalapril diketopiperazine;na mkpebi, R, n'etiti enalapril na enalapril diketopiperazine abụghị ihe na-erughị 3.5.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- Wepụ iche nha nha nha (ihe dịka 50 µL) nke nkwadebe ọkọlọtọ na nkwadebe Assay n'ime chromatograph, dekọọ chromatogram, wee tụọ nzaghachi maka ọnụ ọgụgụ ndị bụ isi.Gbakọọ ọnụọgụ, na mg, nke C20H28N2O5·C4H4O4 n'ime akụkụ Enalapril Maleate nke usoro a were were:
100C (rU / rS)
nke C bụ ntinye uche, na mg kwa ml, nke USP Enalapril Maleate RS na nkwadebe ọkọlọtọ;na rU na rS bụ nzaghachi kacha elu enwetara site na nkwadebe Assay na nkwado ọkọlọtọ, n'otu n'otu.