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DEXCLORPHENIRAMIN MALEAT - DEXCLORPHENIRAMIN MALEAT...

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DEXCLORPHENIRAMIN MALEAT Dexclorpheniramini maleas C 16 H 19 ClN 2 .C 4 H 4 O 4 P.t.l: 390,9 Dexclorpheniramin maleat là (3S)-3-(4-clorophenyl)-N,N-dimethyl-3-(pyridin-2-yl)propan-1-amin (Z)- butandioat, ph i ch a t 98,0 đ n 100,5% C ế 16 H 19 ClN 2 .C 4 H 4 O 4 , tính theo ch ph m đã làm khô. ế Tính ch t B t k t tinh màu tr ng. ế R t tan trong n c, d tan trong ethanol 96%, methanol và methylen clorid. ướ Đ nh tính Có th ch n 1 trong 2 nhóm đ nh tính sau: Nhóm I: A,C, E. Nhóm II: B, C, D, E. A. Ph h ng ngo i c a ch ph m (Ph l c 4.2) ph i phù h p v i ph h ng ngo i c a ế dexclorpheniramin maleat chu n (ĐC). B. Đi m ch y: t 110 o C đ n 115 ế o C (Ph l c 6.7). ụ ụ C. Ph i đáp ng phép th Góc quay c c riêng. D. Ph ng pháp s c ký l p m ng (Ph l c 5.4). ươ ụ ụ B n m ng: Silicagel GF 254 (TT). Dung môi khai tri n: N c - acid formic khan - methanol - di-isopropyl ether ướ (3 : 7 : 20 : 70). Dung d ch th : Hoà tan 0,10 g ch ph m trong ế methanol (TT) và pha loãng thành 5,0 ml v i cùng dung môi. Dung d ch đ i chi u: ế Hoà tan 56 mg acid maleic (TT) trong methanol (TT) và pha loãng thành 5,0 ml v i cùng dung môi. Cách ti n hành: ế Ch m riêng bi t lên b n m ng 5 μl m i dung d ch trên. Tri n khai s c ký đ n khi dung môi đi đ c ế ượ 12 cm. Đ khô b n m ng ngoài không khí và quan sát d i ánh sáng t ngo i b c sóng 254 nm. ướ ạ ở ướ S c ký đ c a dung d ch th ph i cho 2 v t tách rõ ràng, v t phía trên ph i có v trí và kích th c ế ế ướ t ng ng v i v t trên s c ký đ c a dung d ch đ i chi u. ươ ế ế E. Cân 0,15 g ch ph m vào chén s , thêm 0,5 g ế natri carbonat khan (TT) . Đ t kho ng 10 phút, đ ngu i. Hoà tan c n trong 10 ml
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