Zidovudin - ZIDOVUDIN Zidovudinum C10H13N5O4 P.t.l: 267,2...

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ZIDOVUDIN Zidovudinum C 10 H 13 N 5 O 4 P.t.l: 267,2 Zidovudin laø 1-(3-azido-2,3-dideoxy- β -D- erythro -pentofuranosyl)-5- methylpyrimidin-2,4-(1 H ,3 H )-dion, phaûi chöùa töø 97,0 ñeán 102 % C 10 H 13 N 5 O 4 tính theo cheá phaåm ñaõ laøm khoâ. Tính chaát Boät traéng hoaëc aùnh naâu. Hôi tan trong nöôùc, tan trong ethanol. Ñieåm chaûy khoaûng 124 o C. Daïng voâ ñònh hình. Ñònh tính Phoå hoàng ngoaïi (Phuï luïc 4.2) cuûa cheá phaåm phaûi phuø hôïp vôùi phoå hoàng ngoaïi cuûa zidovudin chuaån (ÑC). Neáu phoå thu ñöôïc töø daïng raén coù söï khaùc bieät, tieán haønh hoøa tan cheá phaåm vaø chaát chuaån rieâng reõ trong moät löôïng toái thieåu nöôùc sau ñoù bay hôi ñeán khoâ trong bình huùt aåm döôùi aùp suaát giaûm vaø coù maët cuûa diphosphor pentoxyd (TT). Ghi vaø so saùnh phoå môùi cuûa caùc caén thu ñöôïc. Maøu saéc cuûa dung dòch Hoøa tan 0,5 g cheá phaåm trong 50 ml nöôùc , ñun noùng neáu caàn thieát. Maøu cuûa dung dòch thu ñöôïc khoâng ñöôïc ñaäm hôn maøu maãu VN 5 (Phuï luïc 9.3; Phöông phaùp 2). Goùc quay cöïc rieâng Töø + 60,5 o ñeán + 63,0 o , tính theo cheá phaåm ñaõ laøm khoâ (Phuï luïc 6.4). Hoøa tan 0,50 g cheá phaåm trong ethanol (TT) vaø pha loaõng thaønh 50,0 ml vôùi cuøng dung moâi. Duøng dung dòch thu ñöôïc ño ôû 25 o C. Taïp chaát lieân quan A. Kieåm tra baèng phöông phaùp saéc kyù lôùp moûng (Phuï luïc 5.4) Baûn moûng : Silica gel GF 254 (TT). Dung moâi trieån khai : Methanol - methylen clorid (10 : 90). Dung dòch thöû : Hoøa tan 0,2 g cheá phaåm trong methanol (TT) vaø pha loaõng thaønh 10 ml vôùi cuøng dung moâi. Dung dòch ñoái chieáu (1): Hoøa tan 20 mg moãi chaát sau ñaây: thymin (TT), taïp chaát ñoái chieáu A cuûa zidovudin, triphenylmethanol (TT) trong methanol (TT) , theâm 1,0 ml dung dòch thöû vaø pha loaõng thaønh 100 ml baèng
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This note was uploaded on 12/28/2011 for the course PHARMACEUT 101 taught by Professor Yentrang during the Spring '11 term at Albany College of Pharmacy and Health Sciences.

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Zidovudin - ZIDOVUDIN Zidovudinum C10H13N5O4 P.t.l: 267,2...

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