Vin nn amoxicilin

Tabellae Amoxicillini

 

L vin nn cha amoxicilin trihydrat.

Ch phm phi p ng cc yu cu trong chuyn lun Thuc vin nn (Ph lc 1.20) v cc yu cu sau y:

Hm lng amoxicilin, C16H19N3O5S, t 90,0 n 120,0% so vi hm lng ghi trn nhn (tnh theo ch phm khan).

 

Tnh cht

Vin mu trng hay trng ng, gn nh khng mi.

 

nh tnh

A.     Phng php sc k lp mng (Ph lc 5.4)

Bn mng: Silicagel G dy khong 0,25 mm, hot ho 100oC trong 1 gi.

Dung mi khai trin: Aceton - nc - toluen - acid acetic bng (65 : 10 : 10 : 2,5)

Dung dch th: Lc mt lng bt vin tng ng 100 mg amoxicilin trong 20 ml hn hp gm aceton - acid hydrocloric 0,1 N (4 : 1). Lc.

Dung dch chun: Dung dch amoxicilin 0,5% trong hn hp gm aceton-acid hydrocloric 0,1 N (4:1).

Cch tin hnh: Chm ring bit 2 ml mi dung dch trn ln bn mng. Trin khai sc k n khi dung mi i c khong 15 cm, ly bn mng ra, kh nhit phng. Phun dung dch ninhydrin 0,3% trong ethanol (TT), ri sy 90 oC trong 15 pht. Quan st di nh sng thng. Vt chnh trn sc k ca dung dch th v dung dch chun phi ging nhau v mu sc v gi tr Rf.

B. Thi gian lu ca pic chnh trn sc k ca dung dch th trong phn nh lng phi tng ng vi thi gian lu ca pic ca dung dch chun.

Nc

Khng c qu 13,0% (Ph lc 10.3).

Dng khong 0,15 g bt vin.

 

ho tan (Ph lc 11.4 )

Mi trng ho tan: 900 ml nc.

Thit b: Kiu cnh khuy.

Tc quay : 75 vng/pht.

Thi gian: 60 pht.

Cch tin hnh: Ly mt lng dung dch, lc, b 10 ml dch lc u, pha long nu cn. o hp th bc sng cc i khong 272 nm (Ph lc 4.1), trong cc o dy 1 cm, mu trng l nc . So snh vi dung dch amoxicilin trihydrat chun trong nc c nng tng ng. Tnh hm lng ca amoxicilin.

Yu cu: Khng c t hn 80,0% lng amoxicilin ,C16H19N3O5S , so vi lng ghi trn nhn c ho tan trong 60 pht.

nh lng Tin hnh phng php sc k lng (Ph lc 5.3 )

Dung dch A: Ho tan 13,6 g kali dihydrophosphat (TT) trong 2000 ml nc, iu chnh ti pH 5,0 0,1 vi dung dch kali hydroxyd 45%.

Pha ng : Hn hp Dung dch A v acetonitril (TT) t l (96 : 4). iu chnh t l acetonitril t iu kin sc k yu cu (nu cn).

Dung dch chun: Pha amoxicilin trihydrat chun trong dung dch A c nng amoxicilin chnh xc khong 1,2 mg/ml (ch dng trong vng 6 gi).

Dung dch th: Cn 20 vin, tnh khi lng trung bnh, ri nghin thnh bt mn. Cn chnh xc mt lng bt mn tng ng khong 0.2 g amoxicilin, pha trong dung dch A va 200,0 ml; lc siu m ho tan v lc qua mng lc khng qu 1 mm; (ch dng trong vng 6 gi).

iu kin sc k: Ct thp khng g, c nhi pha tnh C (25 cm 4 mm, c ht t 3 n 10 mm).

Detector quang ph t ngoi t bc sng 230 nm.

Tc dng: 1,5 ml/pht.

Th tch tim: 10 ml.

Cch tin hnh:

Kim tra kh nng thch hp ca h thng: Tim dung dch chun, h s dung lng phi nm trong khong 1,1 n 2,8. S a l thuyt ca ct khng nh hn 1700; h s i xng khng ln hn 2,5 v lch chun tng i ca cc din tch pic t 6 ln tim lp li mu chun khng ln hn 2,0%.

Tim ring bit dung dch th v dung dch chun.

Tnh hm lng amoxicilin, C16H19N3O5S , trong vin t din tch pic trn sc k ca dung dch chun v dung dch th, v hm lng C16H19N3O5S trong amoxicilin trihydrat chun.

Bo qun

ni mt, trong ng kn, trnh nh sng.

Loi thuc

Loi thuc

Khng sinh nhm beta lactam

Hm lng thng dng

250 mg, 500 mg, tnh theo amoxicilin khan