Enalapril Maleate CAS 76095-16-4 Assay 98.0 ~ 102.0% API Babban Tsabta

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 ya ƙunshi bai wuce kashi 98.0 ba kuma bai wuce kashi 102.0 na C20H28N2O5 · C4H4O4 ba, an ƙididdige shi akan busasshiyar tushe.
Marufi da ajiya-Ajiye a cikin kwantena da aka rufe da kyau, da adanawa a yanayin zafin ɗakin da aka sarrafa.
Matsayin Magana na USP <11>-
USP Enalapril Maleate RS Danna don Duba Tsarin
Ganewa-
A: Ciwon Infrared <197M>.
B: Lokacin riƙewa na babban kololuwa a cikin chromatogram na shirye-shiryen Assay ya dace da abin da ke cikin chromatogram na daidaitaccen shiri, kamar yadda aka samu a cikin Assay.
Takamaiman juyawa <781S>: tsakanin -41.0 da -43.5.
Maganin gwaji: 10 MG kowace ml, a cikin methanol.
Asarar bushewa <731>-Busar da shi a cikin injin daskarewa a matsa lamba wanda bai wuce 5 mm na mercury ba a cikin awanni 60 na awanni 2: bai wuce 1.0% na nauyinsa ba.
Ragowa akan kunnawa <281>: bai wuce 0.2% ba.
Karfe masu nauyi, Hanyar II <231>: 0.001%.
Abubuwan da ke da alaƙa-
pH 6.8 Phosphate buffer, pH 2.5 Phosphate buffer, Magani A, Magani B, Wayar hannu lokaci, Diluent, Enalapril diketopiperazine bayani, Tsarin dacewa da tsarin, da tsarin Chromatographic - Ci gaba kamar yadda aka umurce a cikin Assay.
Daidaitaccen bayani-Narkar da daidaitaccen adadin USP Enalapril Maleate RS a cikin Diluent, kuma a tsoma su da yawa, kuma a mataki-mataki idan ya cancanta, tare da Diluent don samun maganin da yake da sananniya na kusan 3 µg kowace ml.
Maganin gwaji-Yi amfani da shirye-shiryen Assay.
Tsari-Na dabam allura daidai juzu'i (kimanin 50 µL) na daidaitaccen bayani da maganin Gwaji a cikin chromatograph, yi rikodin chromatograms, da auna martanin yanki kololuwa.Ƙirƙiri adadin kowane ƙazanta a cikin ɓangaren Enalapril Maleate wanda aka ɗauka ta dabara:
100 (CS / CT) (ri / rS)
wanda CS shine maida hankali, a cikin MG kowace ml, na USP Enalapril Maleate RS a cikin daidaitaccen bayani;CT shine maida hankali, a cikin MG kowace ml, na Enalapril Maleate a cikin maganin gwajin;ri shine mafi girman yanki na kowane ƙazanta da aka samu daga maganin gwajin;kuma rS shine mafi girman yanki na enalapril da aka samu daga daidaitaccen bayani: bai wuce 1.0% na kowane ƙazanta da ke da lokacin riƙewa na kusan 1.10 ba;ba fiye da 0.3% na kowane ƙazanta na kowane mutum da aka samu ba;kuma ba a sama da kashi 2% na ƙazanta duka ba.
Assay-
pH 6.8 Phosphate buffer-Narke 2.8 g na monobasic sodium phosphate a cikin kusan 900 ml na ruwa a cikin filaye mai girma na 1000-ml.Daidaita tare da 9M sodium hydroxide bayani zuwa pH na kusan 6.8, tsarma da ruwa zuwa girma, da haɗuwa.
pH 2.5 Phosphate buffer-Narke 2.8 g na monobasic sodium phosphate a cikin kusan 900 ml na ruwa a cikin filaye mai girma na 1000-ml.Daidaita tare da phosphoric acid zuwa pH na kusan 2.5, tsarma da ruwa zuwa ƙara, da haɗuwa.
Magani A-Shirya cakuda mai tacewa da tsagewar pH 6.8 Fosphate buffer da acetonitrile (19:1).
Magani B-Shirya cakudaccen tacetonitrile da kuma pH 6.8 Phosphate buffer (33:17).
Lokacin wayar hannu-Yi amfani da gauraya masu canji na Magani A da Magani B kamar yadda aka umurce su don tsarin Chromatographic.Yi gyare-gyare idan ya cancanta (duba Dacewar Tsarin ƙarƙashin Chromatography 621).
Diluent-Shirya cakuda pH 2.5 Phosphate buffer da acetonitrile (95:5).
Maganin Enalapril diketopiperazine-A hankali sanya kusan 20 MG na USP Enalapril Maleate RS a cikin bututun miliyon 100 don samar da tudu a ƙasan beaker.Sanya beaker akan farantin zafi a kusan rabin matsakaicin saitin zafin farantin zafi.Gasa na kimanin minti 5 zuwa 10 har sai daskararrun ya narke.Nan da nan cire beaker daga farantin zafi, kuma ba da izinin sanyi.[bayanin kula-Ka guje wa zafi fiye da kima don hana lalatawar zafi, wanda zai haifar da launin ruwan kasa.] Zuwa ragowar da aka sanyaya a cikin beaker ƙara 50 ml na acetonitrile, da sonicate na 'yan mintuna kaɗan don narkewa.Maganin yawanci ya ƙunshi, a cikin kowane ml, tsakanin 0.2 MG da 0.4 MG na enalapril diketopiperazine.
Daidaitaccen shiri-Narkar da daidaitaccen adadin USP Enalapril Maleate RS a cikin Diluent, kuma a tsoma shi da yawa, da kuma mataki-mataki idan ya cancanta, tare da Diluent don samun maganin da ke da sananniya na kusan 0.3 MG kowace ml.
Maganin dacewa da tsarin-Ƙara 1 ml na maganin Enalapril diketopiperazine zuwa wani yanki na 50-ml na daidaitaccen shiri, da haɗuwa.
Shirye-shiryen Assay- Canja wurin kusan 30 MG na Enalapril Maleate, daidai aunawa, zuwa filaye mai girma na 100-mL, narke a ciki kuma a tsoma tare da Diluent zuwa ƙara, da haɗuwa.
Tsarin Chromatographic (duba Chromatography <621>) -Chromatograph na ruwa yana sanye da na'urar ganowa na 215-nm da ginshiƙi na 4.1-mm × 15-cm wanda ya ƙunshi tattara L21.Matsakaicin kwarara shine kusan 1.5 ml a minti daya.Ana kiyaye zafin jiki na ginshiƙi a 70. An tsara chromatograph kamar haka.
Lokaci(mintuna) Magani A(%) Magani B(%) Elution
0 95 5 daidaitawa
0-20 95→40 5→60 layin layi
20-25 40 60 masu bautar gumaka
25-26 40→95 60→5 layin layi
26-30 95 5 masu zaman kansu
Chromatograph da tsarin dacewa da tsarin, da yin rikodin martanin kololuwa kamar yadda aka ba da umarni don Tsari: lokutan riƙewa dangi kusan 1.0 na enalapril da 2.1 na enalapril diketopiperazine;da ƙuduri, R, tsakanin enalapril da enalapril diketopiperazine bai kasa da 3.5 ba.Chromatograph da Daidaitaccen shiri, da rikodin mafi girman martani kamar yadda aka ba da umarni don Tsari: madaidaitan ma'auni don maimaita alluran bai wuce 1.0% ba.
Tsari- Na dabam allura daidai juzu'i (kimanin 50 µL) na daidaitaccen shiri da shirye-shiryen Assay a cikin chromatograph, yi rikodin chromatograms, da auna martani ga manyan kololuwa.Yi ƙididdige adadin, a cikin MG, na C20H28N2O5 · C4H4O4 a cikin ɓangaren Enalapril Maleate wanda aka ɗauka ta dabara:
100C (rU / rS)
wanda C shine maida hankali, a cikin MG da ml, na USP Enalapril Maleate RS a cikin Shirye-shiryen Daidaitawa;da rU da rS sune mafi girman martanin da aka samu daga shirye-shiryen Assay da Daidaitaccen shiri, bi da bi.