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Mefloquin - MEFLOQUIN HYDROCLORID Mefloquini hydrochloridum...

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MEFLOQUIN HYDROCLORID Mefloquini hydrochloridum C 17 H 16 F 6 N 2 O.HCl P.t.l: 414,8 Mefloquin hydroclorid là (RS)-[2,8-bis(trifluoromethyl)quinolin-4-yl][(2SR)-piperidin-2- yl]methanol hydroclorid, ph i ch a t 99,0 đ n 101,0% C ế 17 H 16 F 6 N 2 O.HCl tính theo ch ph m ế đã làm khô. Tính ch t B t k t tinh tr ng ho c vàng nh t, đa hình. R t khó tan trong n c, d tan trong methanol, tan ế ướ trong ethanol 96%. Ch y kho ng 260 o C kèm theo phân hu . Đ nh tính Có th ch n m t trong hai nhóm đ nh tính sau: Nhóm 1: A, E Nhóm 2: B, C, D, E A. 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 mefloquin hydroclorid chu n (ĐC) . N u có đi m khác gi a hai ph h ng ngo i, hòa tan riêng ế bi t ch ph m và ch t chu n trong ế methanol (TT) , bay h i đ n khô và đo ph h ng ngo i c a ơ ế các c n thu đ c. ượ B. Ti n hành ph ng pháp s c ký l p m ng (Ph l c 5.4) ế ươ ụ ụ B n m ng: Silica gel GF 254 (TT) đã đ c tri n khai b ng h n h p ượ methanol - methylen clorid (20 : 80), s y khô nhi t đ 100 - 105 o C trong 15 phút tr c khi s d ng. ướ Dung môi khai tri n: Acid acetic khan - methanol - methylen clorid (10 : 10 : 80). Dung d ch th : Hòa tan 8 mg ch ph m trong ế methanol (TT) và pha loãng thành 5 ml v i cùng dung môi. Dung d ch đ i chi u (1): ế Hòa tan 8 mg mefloquin hydroclorid chu n (ĐC) trong methanol (TT) và pha loãng thành 5 ml v i cùng dung môi. Dung d ch đ i chi u (2): ế Pha loãng 2,5 ml dung d ch th thành 100 ml b ng methanol (TT) . Dung d ch đ i chi u (3): ế Thêm 1 ml dung d ch quinidin sulfat chu n 0,0016% vào 1 ml dung d ch đ i chi u (2). ế Cách ti n hành: ế Ch m riêng bi t lên b n m ng 20 µl các dung d ch th , dung d ch đ i chi u ế (1) và dung d ch đ i chi u (3). Tri n khai s c ký cho đ n khi dung môi đi đ c ít nh t 10 cm. ế ế ượ Làm khô b n m
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