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Betamethason - BetamethasoN Betamethsonium C22H29FO5 P.t.l...

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BetamethasoN Betamethsonium C 22 H 29 FO 5 P.t.l: 392.5 Betamethason là 9-fluoro-11 β ,17,21-trihydroxy-16 β -methylpregna-1,4-dien-3,20-dion , ph i ch a t 97,0 đ n 103,0% ế C 22 H 29 FO 5 , tính theo ch ph m khan. ế Tính ch t B t k t tinh tr ng hay g n nh tr ng. ế ư Th c t không tan trong n c, ít tan trong ethanol 96%, r t ít tan trong methylen clorid. ế ướ Đ nh tính Có th ch n m t trong 2 nhóm đ nh tính sau: Nhóm I: B, C Nhóm II: A, C, D, E A. Hoà tan 10,0 mg ch ph m trong ế ethanol (TT) và pha loãng thành 100,0 ml v i cùng dung môi. L y 2,0 ml dung d ch cho vào ng thu tinh tròn có nút mài, thêm 10,0 ml dung d ch phenylhydrazin trong acid sulfuric (TT) , tr n đ u và đun trong cách thu 60 ỷ ở o C trong 20 phút. Làm ngu i ngay. Đ h p th (Ph l c 4.1) c a dung d ch thu đ c đo b c sóng 419 nm không đ c l n h n 0,10. ụ ụ ượ ướ ượ ơ B. 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 ụ ụ ế betamethason chu n (ĐC) . N u ph h ng ngo i c a m u th và m u chu n tr ng thái r n khác nhau, thì hoà tan ế riêng bi t ch ph m và ế betamethason chu n (ĐC) trong m t l ng t i thi u ượ methylen clorid (TT) , b c h i đ n khô trên n i cách thu . Ghi ph m i các c n thu đ c. ơ ế ượ C. Ph ng pháp s c ký l p m ng (Ph l c 5.4). ươ ụ ụ B n m ng: Silica gel GF 254 (TT). Dung môi khai tri n: Butanol đã bão hoà v i n c - ướ toluen - ether (5 : 10 : 85). Dung d ch th : Hoà tan 10 mg ch ph m trong h n h p ế methanol - methylen clorid (1 : 9) và pha loãng thành 10 ml v i cùng h n h p dung môi. Dung d ch đ i chi u (1): ế Hoà tan 20 mg betamethason chu n (ĐC) trong h n h p methanol - methylen clorid (1 : 9) và pha loãng thành 20 ml v i cùng h n h p dung môi. Dung d ch đ i chi u (2): ế Hoà tan 10 mg dexamethason chu n (ĐC) trong dung d ch đ i chi u (1) và ế pha loãng thành 10 ml v i cùng dung môi. Cách ti n hành: ế Ch m riêng bi t lên b n m ng 5 μ l m i dung d ch trên. Tri
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