Enalapril Maleate CAS 76095-16-4 Assay 98.0 ~ 102.0% API Nadiifnimada Sare

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 wuxuu ka kooban yahay wax aan ka yarayn boqolkiiba 98.0 oo aan ka badnayn boqolkiiba 102.0 ee C20H28N2O5 · C4H4O4, oo lagu xisaabiyo hab qallalan.
Baakadaha iyo kaydinta-Ku xafid weelasha si fiican u xidhan, oo ku kaydi heerkulka qolka kontaroolan.
Heerarka Tixraaca USP <11>-
USP Enalapril Maleate RS Guji si aad u aragto Qaabdhismeedka
Aqoonsiga -
J: Nuugista Infrared <197M>.
B: Waqtiga haynta ee ugu sarreysa chromatogram-ka diyaarinta Assay waxay u dhigantaa tan ku jirta chromatogram-ka diyaarinta Heerka, sida laga helay Assay.
Wareeg gaar ah <781S>: inta u dhaxaysa -41.0 iyo -43.5.
Xalka tijaabada: 10 mg halkii ml, methanol.
Luminta qalajinta <731>- Ku qalaji faakuum cadaadis aan ka badnayn 5 mm oo meerkuri ah 60 ilaa 2 saacadood: wuxuu luminayaa in aan ka badnayn 1.0% miisaankiisa.
Hadhaaga dabka <281>: aan ka badnayn 0.2%.
Biraha culus, Habka II <231>: 0.001%.
Iskudhisyada la xidhiidha-
pH 6.8 Fosfate Buffer, pH 2.5 Fosfate Buffer, Xalka A, Xalka B, Marxaladda Mobilka, Diluent, Enalapril diketopiperazine xal, Xalka ku habboonaanta nidaamka, iyo nidaamka Chromatographic-ku soco sida lagu faray Assay.
Xalka caadiga ah-Ku milmi tirada saxda ah ee la miisaamay ee USP Enalapril Maleate RS ee Diluent, oo ku milo tiro ahaan, iyo si tartiib tartiib ah haddii loo baahdo, iyadoo la isticmaalayo Diluent si loo helo fiirsashada la og yahay ee ku saabsan 3 µg halkii ml.
Tijaabi xalka-Isticmaal diyaarinta Assay.
Habka-Si gooni ah u duri mugga siman (qiyaastii 50 µL) ee xalka Heerka iyo xalka Tijaabada chromatograph-ka, duub chromatogram-yada, oo cabbir jawaabaha aagga ugu sarreeya.Xisaabi boqolkiiba wasakh kasta ee qaybta Enalapril Maleate ee ay qaadatay qaacidada:
100 (CS / CT) (ri / rS)
taas oo CS ay ku jirto fiirsashada, mg per mL, ee USP Enalapril Maleate RS ee xalka caadiga ah;CT waa fiirsashada, mg per mL, ee Enalapril Maleate ee xalka tijaabada;ri waa meesha ugu sarreysa wasakh kasta oo laga helo xalka Imtixaanka;iyo rS waa meesha ugu sarreysa ee enalapril ee laga helo xalalka caadiga ah: in aan ka badnayn 1.0% wasakh kasta oo leh wakhti qaraabo ah oo ku saabsan 1.10 ayaa la helay;aan ka badnayn 0.3% wasakh kale oo shakhsi ah ayaa la helaa;oo aan ka badnayn 2% wadarta wasakhda la helo.
Imtixaan-
pH 6.8 Fosfate Buffer-Mil 2.8 g oo ah monobasic sodium fosfate ku dhawaad ​​900 ml oo biyo ah 1000-ml oo saxan mug leh.Ku hagaaji 9 M sodium hydroxide xal pH ah oo ku saabsan 6.8, ku qas biyo mugga, oo qas.
pH 2.5 Fosfate Buffer-Mil 2.8 g oo ah monobasic sodium phosphate ilaa 900 ml oo biyo ah 1000-ml oo saxan mug leh.Ku hagaaji fosfooraska acid pH qiyaastii 2.5, ku qas biyo mugga, oo qas.
Xalka A- Diyaari isku dhafka la sifeeyay oo soo degsaday ee pH 6.8 Fosfate buffer iyo acetonitrile (19:1).
Xalka B- Diyaari isku dar la sifeeyay oo soo degsaday oo ah acetonitrile iyo pH 6.8 Fosfate kaydiye (33:17).
Marxaladda mobilada-Isticmaal isku dhafka kala duwan ee Xalka A iyo Xalka B sida lagu faray nidaamka Chromatographic.Samee hagaajin haddii loo baahdo (eeg Habboonaanta Nidaamka ee hoos timaada Chromatography 621).
Diluent- Diyaari isku dhafka pH 2.5 Fosfate buffer iyo acetonitrile (95:5).
Xalka Enalapril diketopiperazine-Si taxadar leh u dhig ilaa 20 mg oo USP Enalapril Maleate RS ah 100-mL beaker si uu tuulmo ugu sameyo xagga hoose ee birta.Ku rid foornada saxan kulul qiyaastii nus ka mid ah goobta heerkulka ugu badan ee saxanka kulul.Kuleyl ilaa 5 ilaa 10 daqiiqo ilaa inta adag uu dhalaalayo.Isla markiiba ka saar basbaaska saxanka kulul, oo u ogolow inuu qaboojiyo.[xusuus- Iska ilaali kulaylka si aad uga hortagto xaalufka kulaylku keeno, kaas oo dhalin doona midab bunni ah.Xalku wuxuu caadi ahaan ka kooban yahay, mL kasta, inta u dhaxaysa 0.2 mg iyo 0.4 mg ee enalapril diketopiperazine.
Diyaarinta caadiga ah-Ku milmi tirada saxda ah ee la miisaamay ee USP Enalapril Maleate RS ee Diluent, oo ku milo tiro ahaan, iyo si tartiib tartiib ah haddii loo baahdo, iyadoo la isticmaalayo Diluent si loo helo fiirsashada la og yahay ee ku saabsan 0.3 mg halkii ml.
Xalka ku habboonaanta nidaamka-Ku dar 1 mL ee xalka Enalapril diketopiperazine qayb 50-mL ee diyaarinta caadiga ah, oo isku qas.
Diyaarinta Assay- Ku wareeji qiyaastii 30 mg ee Enalapril Maleate, si sax ah loo miisaamay, ilaa 100-mL weel mug leh, ku milmi oo ku milmi Diluent si mug leh, oo isku qas.
Nadaamka Chromatographic (eeg Chromatography <621>)-Kromaatograph-ka dareeraha ah waxa uu ku qalabaysan yahay 215-nm bare iyo tiir 4.1-mm × 15-cm ah oo ka kooban xirmo L21.Heerka socodka waa qiyaastii 1.5 mL daqiiqadii.Heerkulka tiirka waxa lagu hayaa 70. chromatograph-ka waxa loo habeeyey sidan soo socota.
Waqtiga(daqiiqado) Xalka A(%) Xalka B(%) Elution
0 95 5 dheellitirka
0-20 95→40 5→60 jaanis toosan
20-25 40 60 isocratic
25-26 40→95 60→5 jaanis toosan
26-30 95 5 isocratic
Chromatograph ee xalka ku habboonaanta nidaamka, oo qor jawaabaha ugu sarreeya sida lagu faray habraaca: waqtiyada sii hayntu waxay ku dhow yihiin 1.0 ee enalapril iyo 2.1 ee enalapril diketopiperazine;iyo xallinta, R, inta u dhaxaysa enalapril iyo enalapril diketopiperazine waa mid aan ka yarayn 3.5.Chromatograph ee heerka diyaarinta, oo diwaangeli jawaabaha ugu sarreeya sida lagu faray Habraaca: jaangooyada heerka qaraabo ee cirbadaha soo noqnoqda kama badna 1.0%.
Habka- Si gooni ah u duri mugga siman (qiyaastii 50 µL) ee diyaarinta Heerka iyo diyaarinta Assay chromatograph-ka, duub chromatogram-yada, oo cabbir jawaabaha meelaha ugu sarreeya.Xisaabi tirada, mg, ee C20H28N2O5·C4H4O4 ee qaybta Enalapril Maleate ee ay qaadatay qaacidada:
100C (rU / rS)
taas oo C ay tahay fiirsashada, mg per mL, ee USP Enalapril Maleate RS ee diyaarinta Heerka;iyo rU iyo rS waa jawaabaha ugu sarreeya ee laga helay diyaarinta Assay iyo heerka diyaarinta, siday u kala horreeyaan.