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Ciprofloxacin - CIPROFLOXACIN HYDROCLORID Ciprofloxacini...

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CIPROFLOXACIN HYDROCLORID Ciprofloxacini hydrochloridum C 17 H 18 FN 3 O 3 .HCl P.t.l: 367,8 Ciprofloxacin hydroclorid là acid 1-Cyclopropyl-6-fluoro-4-oxo-7-(piperazin-1-yl)-1,4- dihydroquinolin-3-carboxylic hydroclorid, ph i ch a t 98,0% đ n 102,0% C ế 17 H 18 FN 3 O 3 .HCl, tính theo ch ph m khan. ế Tính ch t B t k t tinh màu vàng nh t, hút m nh . Tan trong n c, khó tan trong methanol, r t khó tan ế ướ trong ethanol, th c t không tan trong aceton, ethyl acetat và methylen clorid. ế Đ nh tính 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 ciprofloxacin hydroclorid chu n (ĐC). B. Ch ph m cho ph n ng đ nh tính (B) c a ion clorid (Ph l c 8.1). ế ụ ụ Đ trong và màu s c c a dung d ch Dung d ch S: Hòa tan 0,5 g ch ph m trong ế n c không có carbon dioxyd (TT) ướ và pha loãng thành 20 ml v i cùng dung môi. Pha loãng 10 ml dung d ch S thành 20 ml v i n c không có carbon dioxyd (TT). ướ Dung d ch thu đ c ph i trong (Ph l c 9.2) và màu không đ c đ m h n dung d ch màu m u VL ượ ụ ụ ượ ơ 5 (Ph l c ụ ụ 9.3; ph ng pháp 2). ươ pH pH c a dung d ch S ph i t 3,5 đ n 4,5 (Ph l c 6.2) ế ụ ụ Acid fluoroquinolonic Không đ c quá 0,2%. ượ Xác đ nh b ng 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: Acetonitril – amoniac – methanol – methylen clorid (10 : 20 : 40 : 40). Dung d ch th : Hòa tan 50 mg ch ph m trong ế n c ướ và pha loãng thành 5 ml v i cùng dung môi. Dung d ch đ i chi u: ế Hòa tan 10 mg acid fluoroquinolonic chu n (ĐC) trong h n h p g m 0,1 ml amoniac (TT) và 90 ml n c ướ , thêm n c ướ v a đ 100 ml. Pha loãng 2 ml dung d ch thu đ c
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