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Gliclazid Hoa - GLICLAZID Gliclazidum C15H21N3O3S P.t.l...

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GLICLAZID Gliclazidum C 15 H 21 N 3 O 3 S P.t.l: 323,4 Gliclazid là 1-(hexahydrocyclopenta[c]pyrrol-2(1H)-yl)-3-[(4-methylphenyl) sulphonyl] ure, ph i ch a t 99,0 đ n 101,0% ế C 15 H 21 N 3 O 3 S, tính theo ch ph m đã làm khô. ế Tính ch t B t tr ng ho c g n nh tr ng. Th c t không tan trong n c, d tan trong methylen ư ế ướ clorid, h i tan trong aceton, khó tan trong ethanol 96%. ơ Đ nh tính Ph h ng ngo i (Ph l c 4.2) c a ch ph m ph i phù h p v i ph h ng ngo i c a ế gliclazid chu n (ĐC). T p ch t liên quan Xác đ nh b ng ph ng pháp s c ký l ng (Ph l c 5.3). ươ ụ ụ Pha đ ng: Triethylamin - acid trifluoroacetic - acetonitril - n c ướ (0,1: 0,1: 45:55) Chu n b các dung d ch ngay tr c khi dùng. ướ Dung d ch th : Hoà tan 50,0 mg ch ph m trong 23 ml ế acetonitril (TT) và và pha loãng thành 50,0 ml v i cùng dung môi. Dung d ch đ i chi u (1): ế Pha loãng 1,0 ml dung d ch th thành 100 ml b ng h n h p acetonitril - n c ướ (45 : 55). Pha loãng 10,0 ml dung d ch trên thành 100,0 ml v i cùng h n h p dung môi . Dung d ch phân gi i: Hoà 5 mg ch ph m và 15 mg ế t p ch t chu n F c a gliclazid (ĐC) trong 23 ml acetonitril (TT) và pha loãng thành 50 ml v i cùng dung môi. Pha loãng 1,0 ml dung d ch này thành 20 ml b ng h n h p acetonitril - n c ướ (45 : 55).
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