Vin nn loperamid

Tabellae Loperamidi

 

L vin nn cha loperamid hydroclorid.

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 loperamid hydroclorid, C29H33ClN2O2 .HCl, t 90,0 n 110,0% so vi hm lng ghi trn nhn.

 

Tnh cht

Vin mu trng.

 

nh tnh

A. Trong phn nh lng, thi gian lu ca pic chnh trn sc k ca dung dch th phi ging thi gian lu ca pic loperamid sc k ca dung dch chun .

B. Ly mt lng bt vin tng ng khong 10 mg loperamid hydroclorid cho vo ng nghim, thm 20 ml isopropanol (TT). Lc trong 1 pht. lng, ly 9,0 ml dung dch pha trn, thm 1,0 ml dung dch acid hydrocloric 0,1 N (TT), trn u. o ph hp th (Ph lc 4.1) ca dung dch ny trong khong bc sng 250 n 300 nm, ph hp th t ngoi phi c cc i v cc tiu ging nh ph hp th th t ngoi ca dung dch loperamid chun c tin hnh tng t.

 

ho tan (Ph lc 11.4).

Mi trng ho tan: 900 ml Dung dch acid hydrocloric 0,01 N.

Thit b: Kiu cnh khuy.

Tc quay: 50 vng/pht.

Thi gian: 30 pht.

Cch tin hnh: Xc nh bng phng php sc k lng (Ph lc 5,3).

Pha ng v iu kin sc k thc hin theo ch dn trong phn nh lng.

Th tch tim 50 ml.

Dung dch th: Ly mt phn dung dch mi trng ha tan ch phm, lc, b dch lc u.

Tim hnh sc k vi dung dch th v dung dch loperamid hydroclorid chun c nng tng t nh dung dch th, pha trong mi trng ho tan.

Yu cu: Khng c t hn 80,0% lng loperamid hydroclorid, C29H33ClN2O2.HCl, so vi lng ghi trn nhn c ho tan trong 30 pht.

 

ng u hm lng

Phi p ng yu cu v Th ng u hm lng (Ph lc 11.2).

Tin hnh bng phng php sc k lng (Ph lc 5,3).

Pha ng, dung dch chun v iu kin sc k v cch tin hnh thc hin theo ch dn trong phn nh lng.

Dung dch th: Cho vin thuc vo bnh nh mc 200 ml, thm 4 ml dung dch acid phosphoric 5% (TT) v 20 ml methanol (TT), lc cho tan ri thm nc n nh mc, trn u, lc.

 

nh lng

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

Dung dch m: Ho tan 3,0g triethylamin hydroclorid (TT) v 1 ml acid phosphoric (TT) trong 550 ml nc.

Pha ng: Hn hp acetonitril (TT) v dung dch m (45 : 55). C th iu chnh t l nu cn.

Dung dch th: Cn 20 vin, tnh khi lng trung bnh ca vin, nghin thnh bt mn. Cn chnh xc mt lng bt vin tng ng vi khong 8 mg loperamid hydroclorid vo bnh nh mc 1000 ml, thm 20 ml dung dch acid phosphoric 5% (TT) v 100 ml methanol (TT), lc siu m trong 30 pht. Pha long bng nc va th tch.

Dung dch chun: Cn chnh xc khong 50 mg loperamid HCl chun ho tan trong nc va 250 ml. Ly chnh xc 10,0 ml dung dch ny cho vo bnh nh mc 250 ml, thm 5,0 ml dung dch acid phosphoric 5% (TT), 25 ml methanol (TT) v thm nc n nh mc, trn u.

iu kin sc k:

Ct thp khng g (8 cm 4 mm) nhi pha tnh B (5mm).

Detector quang ph t ngoi, t bc sng 214 nm.

Tc dng: 2,0 ml/pht.

iTh tch tim: 20 ml.

Cch tin hnh:

Tin hnh sc k vi dung dch chun, h s i xng ca pic loperamid hydroclorid phi khng ln hn 2,0 v lch chun tng i ca din tch pic thu c trn sc k ca 6 ln tim lp li khng ln hn 2,0%.

Tnh hm lng loperamid hydroclorid, C29H33ClN2O2 .HCl, trong mt vin da vo din tch pic trn sc k ca dung dch chun, dung dch th v hm lng C29H33ClN2O2 .HCl trong loperamid hydroclorid chun.

Bo qun

Trong ng kn, trnh nh sng, nhit khng qu 30 OC.

 

Loi thuc

Thuc tr i chy

 

Hm lng thng dng

2 mg, tnh theo loperamid hydroclorid.