TINIDAZOL

C8H13N3O4S P.t.l: 247,3

Tinidazol l 1-[2-(ethylsulfonyl)ethyl]-2-methyl-5-nitro-1H-imidazol, phi cha t 98,0 % n 101,0 %
C8H13N3O4S tnh theo ch phm lm kh.

Tnh cht
Bt kt tinh gn nh trng hoc vng nht, thc t khng tan trong nc, tan trong aceton v trong
methylen clorid, hi tan trong methanol.

nh tnh
C th chn 1 trong 2 nhm nh tnh sau:
Nhm I: A, C.
Nhm II: B, C, D, E.
A. Ph hp th hng ngoi (Ph lc 4.2) ca ch phm phi ph hp vi ph hp th hng ngoi ca
tinidazol chun.
B. Ha tan 10,0 mg ch phm vo methanol (TT) ri pha long n 100,0 ml vi cng dung mi. Pha
long 1,0 ml dung dch thu c thnh 10,0 ml vi methanol (TT). Ph hp th t ngoi (Ph lc 4.1)
ca dung dch trong khong bc sng t 220 nm n 350 nm c hp th cc i 310 nm. hp
th ring bc sng cc i t 340 n 360.
C. im chy ca ch phm phi t 125 C n 128 C (Ph lc 6.7).
D. Phng php sc k lp mng (Ph lc 5.4).
Bn mng: Silica gel GF254. Hot ha 110 C trong 1 h v ngui.
Dung mi khai trin: Butanol - ethyl acetat (25 : 75).
Dung dch th: Ha tan 20 mg ch phm trong methanol (TT) v pha long thnh 10 ml vi cng dung
mi.
Dung dch i chiu: Ha tan 20 mg tinidazol chun trong methanol (TT) v pha long thnh 10 ml vi
cng dung mi.
Cch tin hnh: Chm ring bit ln bn mng 10 l mi dung dch trn. Trin khai sc k ti khi dung
mi i c 2/3 chiu di bn mng. kh bn mng ngoi khng kh v quan st di nh sng t
ngoi bc sng 254 nm. Vt chnh trn sc k ca dung dch th phi c v tr v kch thc
tng t vi vt chnh trn sc k ca dung dch i chiu.
E. Ly khong 10 mg ch phm, thm khong 10 mg bt km (TT), 0,3 ml acid hydrocloric (TT) v 1 ml
nc. un trong cch thy 5 min ri ngui. Dung dch cho phn ng ca amin thm bc nht ( Ph
lc 8.1).

trong v mu sc ca dung dch

Ha tan 1,0 g ch phm trong aceton (TT) v pha long thnh 20 ml vi cng dung mi.
Dung dch thu c phi trong (Ph lc 9.2) v khng c c mu m hn mu mu V 5 (Ph lc 9.3,
phng php 2).

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Tp cht lin quan
Phng php sc k lng (Ph lc 5.3). Chun b cc dung dch trong iu kin trnh nh sng.
Pha ng: Acetonitril - methanol - nc (10 : 20 : 70).
Dung dch th: Ha tan 10,0 mg ch phm trong 10,0 ml methanol (TT) v pha long thnh 100,0 ml
bng pha ng.
Dung dch i chiu (1): Pha long 1,0 ml dung dch th thnh 100,0 ml bng pha ng. Pha long
1,0 ml dung dch thu c thnh 10,0 ml bng pha ng.
Dung dch i chiu (2): Ha tan 5,0 mg tp cht A chun ca tinidazol v 5,0 mg tp cht B chun ca
tinidazol trong 10,0 ml methanol (TT) v pha long thnh 100,0 ml bng pha ng. Pha long 2,0 ml
dung dch thu c thnh 10,0 ml bng pha ng.
Dung dch i chiu (3): Pha long 1,0 ml dung dch i chiu (2) thnh 50,0 ml bng pha ng.
iu kin sc k:
Ct kch thc 25 cm 3,0 mm c nhi pha tnh B (5 m).
Detector quang ph hp th t ngoi t bc sng 320 nm.
Tc dng: 0,5 ml/min.
Th tch tim: 20 l.
Cch tin hnh:
Tin hnh sc k vi thi gian gp 1,5 ln thi gian lu ca tinidazol.
Thi gian lu tng i so vi tinidazol (thi gian lu khong 6 min): Tp cht A khong 0,6; tp cht B
khong 0,7.
Kim tra tnh ph hp ca h thng: Trn sc k ca dung dch i chiu (2), phn gii gia pic
ca tp cht A v pic ca tp cht B t nht l 2,0.
Gii hn:
Tp cht A, B: Vi mi tp cht, din tch pic khng c ln hn din tch pic chnh thu c trn sc
k ca dung dch i chiu (3) (0,2 %).
Tp cht khc: Vi mi tp cht, din tch pic khng c ln hn din tch pic chnh trn sc k
ca dung dch i chiu (1) (0,10 %).
Tng din tch pic ca tt c cc tp cht khng c ln hn 4 ln din tch pic chnh thu c trn
sc k ca dung dch i chiu (1) (0,4 %).
B qua nhng pic c din tch nh hn 0,5 ln din tch pic chnh thu c trn sc k ca dung
dch i chiu (1) (0,05 %).
Ghi ch:
Tp cht A: 2-methyl-5-nitro-1H-imidazol.
Tp cht B: 1-[2-(ethylsulphonyl)ethyl]-2-methyl-4-nitro-1H-imidazol.

Kim loi nng

Khng c qu 20 phn triu (Ph lc 9.4.8).
Ly 1,0 g ch phm tin hnh theo phng php 4. Dng 2 ml dung dch ch mu 10 phn triu Pb
(TT) chun b mu i chiu.

Mt khi lng do lm kh
Khng c qu 0,5 % (Ph lc 9.6).
(1,000 g; 105 oC).

Tro sulfat
Khng c qu 0,1 % (Ph lc 9.9, phng php 2).
Dng 1,0 g ch phm.

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nh lng
Ha tan 0,150 g ch phm trong 25 ml acid acetic khan (TT). nh lng bng dung dch acid percloric
0,1 N (C), xc nh im kt thc bng phng php chun o in th (Ph lc 10.2).
1 ml dung dch acid percloric 0,1 N (C) tng ng vi 24,73 mg C8H13N3O4S.

Bo qun
Trnh nh sng.

Loi thuc
Khng nguyn sinh ng vt, khng sinh.

Ch phm
Vin nn.

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