Vin nn praziquantel

Tabellae Praziquanteli

 

L vin nn cha praziquantel.

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 praziquantel, C19H24N2O2 t 90,0 n 110,0% so vi hm lng ghi trn nhn.

Tnh cht

Vin mu trng.

nh tnh

A. Dung dch ch phm trong phn th ho tan phi c ph hp th t ngoi ging ph ca dung dch praziquantel chun v phi c mt cc i hp th ti bc sng 263 1 nm.

B. Trong phn nh lng, thi gian lu ca pc chnh trn sc k ca dung dch th phi tng ng vi thi gian lu ca pc praziquantel trong sc k ca dung dch chun.

ho tan (Ph lc 11.4).

Thit b: Kiu cnh khuy.

Mi trng ho tan: 900 ml Dung dch acid hydrocloric 0,1 N c cha 2 mg natri lauryl sulfat (TT) cho 1 ml.

Tc quay: 50 vng/pht.

Thi gian: 60 pht.

Cch tin hnh: Ly mt phn dung dch mi trng sau khi ha tan, lc, b 20 ml dch lc u, pha long dch lc thu c ti nng thch hp vi mi trng ha tan (nu cn). o hp th (Ph lc 4.1) ca dung dch thu c bc sng cc i 263 1 nm, cc o dy 1 cm, mu trng l mi trng ho tan. So snh vi dung dch praziquantel chun 0,06% trong mi trng ho tan. Tnh ra lng praziquantel, C19H24N2O2, ho tan da vo cc hp th o c v nng C19H24N2O2 trong dung dch chun.

Yu cu: Khng c t hn 75,0% lng praziquantel so vi lng ghi trn nhn c ho tan trong 60 pht.

 

nh lng

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

Pha ng: Hn hp acetonitril- nc (60 : 40), iu chnh t l nu cn.

Dung dch chun: Ho tan mt lng chnh xc praziquantel chun trong pha ng c dung dch c nng 0,18 mg/ ml.

Dung dch th: Cn 20 vin, tnh khi lng trung bnh v nghin thnh bt mn. Cn chnh xc mt lng bt vin tng ng vi khong 0,15 g praziquantel cho vo bnh nh mc 100 ml, thm 70 ml pha ng, lc siu m 5 pht, thm pha ng n nh mc, lc u. Lc. Pha long 3,0 ml dch lc thu c thnh 25 ml bng pha ng, lc u.

iu kin sc k:

Ct thp khng g (25 cm 4 mm) c nhi pha tnh C (10 mm).

Detector quang ph t ngoi t bc sng 210 nm.

Tc dng: 1,5 ml/pht.

Th tch tim: 10 ml.

Cch tin hnh:

Kim tra kh nng thch hp ca h thng sc k: Tin hnh sc k vi dung dch chun, h s i xng khng c ln hn 1,5 v lch chun tng i ca din tch pc trn sc k ca cc ln tim lp li khng ln hn 1,0%.

Tin hnh sc k ln lt vi dung dch chun v dung dch th.

Tnh hm lng praziquantel,C19H24N2O2 , trong vin da vo din tch pc trn sc k ca dung dch chun, dung dch th v hm lng C19H24N2O2 ca praziquantel chun.

 

Bo qun

Trong ng kn, nhit di 30 OC.

 

Loi thuc

Thuc dit giun sn.

 

Hm lng thng dng

600 mg.