Enalapril Maleate CAS 76095-16-4 Assay 98.0~102.0% API High Purity

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 e na le liperesente tse seng ka tlase ho 98.0 mme eseng ho feta liperesente tse 102.0 tsa C20H28N2O5·C4H4O4, tse baloang ka mokhoa o omisitsoeng.
Packaging le ho boloka-Ho boloka ka lijaneng tse koetsoeng hantle, 'me u boloke mocheso oa kamore o laoloang.
USP Reference standards <11>-
USP Enalapril Maleate RS Tobetsa ho Sheba Sebopeho
Boitsebiso-
A: Infrared Absorption <197M>.
B: Nako ea ho boloka tlhoro e kholo ea chromatogram ea boitokisetso ba Assay e lumellana le e ho chromatogram ea Tokisetso e Tloaelehileng, joalo ka ha e fumanoe ho Assay.
Potoloho e khethehileng <781S>: pakeng tsa -41.0 le -43.5.
Tharollo ea teko: 10 mg ka mL, ka methanol.
Ho lahleheloa ke ho omisa <731> -E omise ka vacuum ka khatello e sa feteng 5 mm ea mercury ka 60 bakeng sa lihora tse 2: e lahleheloa ke boima ba eona ho feta 1.0%.
Masala a ho khantša <281>: eseng ho feta 0.2%.
Litšepe tse boima, Mokhoa oa II <231>: 0,001%.
Likopano tse amanang-
pH 6.8 Phosphate buffer, pH 2.5 Phosphate buffer, Tharollo A, Tharollo B, Mobile phase, Diluent, Enalapril diketopiperazine solution, System suitability solution, le Chromatographic system— Tsoela pele joalokaha ho laetsoe ho Assay.
Tharollo e tloahelehileng-Hlakola palo e lekantsoeng e nepahetseng ea USP Enalapril Maleate RS ho Diluent, 'me u hlapolle ka bongata, le ka mohato oa mohato ha ho hlokahala, ka Diluent ho fumana tharollo e nang le kholiso e tsebahalang ea hoo e ka bang 3 µg ka mL.
Tharollo ea teko-Sebelisa ho lokisetsa Assay.
Ts'ebetso-Ka karohano kenya meqolo e lekanang (hoo e ka bang 50 µL) ea tharollo e tloaelehileng le Tharollo ea Teko ka har'a chromatograph, rekota li-chromatogram, 'me u lekanye likarabelo tsa sebaka se phahameng.Bala liperesente tsa ho se hloeke ka 'ngoe karolong ea Enalapril Maleate e nkiloeng ka foromo:
100(CS / CT)(ri / rS)
moo CS e leng mahloriso, ka mg ka mL, ea USP Enalapril Maleate RS ka tharollo ea Standard;CT ke mahloriso, ka mg ka mL, ea Enalapril Maleate ka tharollo ea Tlhahlobo;ri ke tlhōrō ea sebaka se seng le se seng sa litšila tse fumanoang ho tsoa ho Tharollo ea Tlhahlobo;'me rS ke sebaka se phahameng sa enalapril se fumanoang ho tsoa Tharollong ea Maemo: ha ho fete 1.0% ea litšila leha e le life tse nang le nako ea ho boloka nako e ka bang 1.10 e fumanoa;ha ho fete 0.3% ea litšila tse ling tse fumanoang;mme ha se fete 2% ya ditshila kaofela tse fumanwang.
Tlhahlobo-
pH 6.8 Phosphate buffer-Hlakola 2.8 g ya monobasic sodium phosphate sebakeng se ka bang 900 ml ya metsi ka hara botlolo ya volumetric ya 1000-mL.Fetola ka tharollo ea 9 M sodium hydroxide ho pH e ka bang 6.8, hlapolla ka metsi ho isa bophahamong, 'me u kopanye.
pH 2.5 Phosphate buffer-Hlakola 2.8 g ya monobasic sodium phosphate sebakeng se ka bang 900 ml ya metsi ka hara botlolo ya volumetric ya 1000-mL.Fetola ka asiti ea phosphoric ho pH e ka bang 2.5, hlapolla ka metsi ho ea bophahamong, 'me u kopanye.
Tharollo A-Lokisetsa motsoako o sefiloeng le o sentsoeng oa pH 6.8 Phosphate buffer le acetonitrile (19:1).
Tharollo B-Lokisetsa motsoako o sefiloeng le o sentsoeng oa acetonitrile le pH 6.8 Phosphate buffer (33:17).
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-Lokisetsa motsoako oa pH 2.5 Phosphate buffer le acetonitrile (95:5).
Enalapril diketopiperazine solution-Beha ka hloko hoo e ka bang 20 mg ea USP Enalapril Maleate RS ka har'a beakere ea 100-mL ho etsa tutulu ka tlase ho beakere.Bea beake holim'a poleiti e chesang hoo e ka bang halofo ea boholo ba mocheso oa hot plate.Chesa metsotso e ka bang 5 ho isa ho e 10 ho fihlela se tiileng se qhibiliha.Hang-hang tlosa beaker ho tloha poleiting e chesang, 'me u lumelle ho pholile.[Hlokomela-Qoba ho chesa haholo ho thibela ho senyeha ho bakoang ke mocheso, ho ka hlahisang 'mala o sootho.] Ho masala a pholileng ka beaker eketsa 50 mL ea acetonitrile,' me u sonicate metsotso e seng mekae ho qhibiliha.Tharollo hangata e na, ho mL ka 'ngoe, lipakeng tsa 0.2 mg le 0.4 mg ea enalapril diketopiperazine.
Tokisetso e tloahelehileng-Hlakola tekanyo e lekantsoeng e nepahetseng ea USP Enalapril Maleate RS ho Diluent, 'me u hlapolle ka bongata, le ka mohato ka mohato ha ho hlokahala, ka Diluent ho fumana tharollo e nang le motsoako o tsebahalang oa hoo e ka bang 0.3 mg ka mL.
Tharollo ea ho tšoaneleha ha Sisteme-Eketsa 1 mL ea tharollo ea Enalapril diketopiperazine karolong ea 50-mL ea tokiso e Tloaelehileng, 'me u kopanye.
Boitokisetso ba tlhahlobo- Fetisetsa hoo e ka bang 30 mg ea Enalapril Maleate, e lekantsoeng ka nepo, ho botlolo ea volumetric ea 100-mL, qhalla le ho hlapolla ka Diluent ho bophahamo, 'me u kopanye.
Chromatographic system (bona Chromatography <621>) -Mokelikeli oa chromatograph o na le mochine oa 215-nm le kholomo ea 4.1-mm × 15-cm e nang le packing L21.Sekhahla sa phallo ke hoo e ka bang 1.5 mL ka motsotso.Mocheso oa kholomo o bolokiloe ho 70. Chromatograph e hlophisitsoe ka tsela e latelang.
Nako(metsotso) Tharollo A(%) Tharollo B(%) Elution
0 95 5 tekano
0-20 95→40 5→60 mothalo o mothalo
20-25 40 60 isocratic
25-26 40→95 60→5 mothalo o mothalo
26-30 95 5 isocratic
Chromatograph ea tharollo ea ho tšoaneleha ha Sisteme, 'me u tlalehe likarabelo tse phahameng joalo ka ha li laetsoe bakeng sa Tsamaiso: linako tse lekanyelitsoeng tsa ho boloka li ka ba 1.0 bakeng sa enalapril le 2.1 bakeng sa enalapril diketopiperazine;mme qeto, R, pakeng tsa enalapril le enalapril diketopiperazine ha e ka tlase ho 3.5.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- Kenya li-volume tse lekanang ka thoko (tse ka bang 50 µL) tsa Tokisetso e Tloaelehileng le boitokisetso ba Assay ho chromatograph, rekota li-chromatogram, 'me u lekanye likarabo tsa litlhoro tse kholo.Bala palo, ka mg, ea C20H28N2O5·C4H4O4 karolong ea Enalapril Maleate e nkiloeng ka foromo:
100C(rU / rS)
moo C e leng mahloriso, ka mg ka mL, ea USP Enalapril Maleate RS ho tokisetso e tloaelehileng;'me rU le rS ke likarabelo tse phahameng tse fumanoeng ho tsoa ho Tokisetso ea Assay le Tokiso ea Maemo, ka ho latellana.