Nang loperamid

Capsulae Loperamidi

 

L nang cng cha loperamid hydroclorid.

Ch phm phi p ng cc yu cu trong chuyn lun Thuc nang (Ph lc 1.13) 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

Nang cng, bt thuc trong nang mu trng.

 

nh tnh

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

B. Phng php sc k lp mng:

Bn mng: silica gel GF254.

Dung mi trin khai: Cloroform- methanol- acid formic (85: 10: 5).

Dung dch th: Lc mt lng bt thuc c cha khong 10 mg loperamid HCl vi 10 ml methanol (TT) trong 5 pht v lc.

Dung dch i chiu: Cha loperamid hydroclorid chun vi nng khong 10 mg/ ml pha trong methanol (TT).

Cch tin hnh: chm 10 ml dung dch th v 1 ml dung dch chun ln bn mng. Sau khi trin khai sc k. kh bn mng ngoi khng kh, sau cho vo bnh hi iod đến khi hiện vết v quan st. Vt chnh trn sc k ca dung dch th phi c cng v tr vi vt trn sc k ca dung dch i chiu.

 

ho tan (Ph lc 11.4).

Mi trng ho tan: 500 ml dung dch m acetat pH 4,7.

Cch pha dung dch m acetat pH 4,7: Thm 200 ml dung dch acid acetic 1 N (TT) vo 600 ml nc, iu chnh n pH 4,70 0,05 bng dung dch natri hydroxyd 1 N(TT) pha long ti 1000 ml bng nc.

Thit b: Kiu gi quay.

Tc quay: 100 vng/pht.

Thi gian: 30 pht.

Cch tin hnh: Xc nh bng phng php sc k lng ( Ph lc 5.3).

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

Dung dch th: Ly mt phn dung dch mi trng ho tan ch phm, lc, b dch lc u. Dung dch chun: Dung dch loperamid hydroclorid chun c nng tng ng 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 theo ch dn trong phn nh lng.

Dung dch th: Cho lng thuc trong 1 nang vo bnh nh mc 10 ml, thm 3,5 ml dung dch acid hydrocloric 0,5N (TT), lc siu m 15 pht. Thm 3,5 ml acetonitril (TT) ri lc siu m thm 15 pht na. Sau thm hn hp ng th tch acetonitrtil (TT) v dung dch HCl 0,5N (TT) n nh mc, trn u v lc. Ly chnh xc 5,0 ml dch lc, pha long bng hn hp ng th tch acetonitril (TT) v nc ti th tch 100 ml, trn u v lc.

 

nh lng

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

Pha ng: Ly 500 ml acetonitril (TT) pha long thnh 1000 ml bng nc, thm 20 git acid phosphoric (TT), lc u. iu chnh nu cn.

Dung dch th: Cn 20 nang, tnh khi lng trung bnh ca bt thuc trong nang, nghin thnh bt mn. Cn chnh xc mt lng bt ch phm tng ng vi khong 20 mg loperamid hydroclorid vo bnh nh mc 100 ml, thm 35 ml dung dch acid hydrocloric 0,5 N (TT), lc siu m 15 pht. Thm 35 ml acetonitril (TT) v lc siu m thm 15 pht na. Sau pha long bng hn hp ng th tch acetonitril v dung dch acid hydrocloric 0,5 N (TT) n nh mc. Trn u v lc. Ly chnh xc 5,0 ml dch lc pha long bng hn hp ng th tch acetonitril (TT) v nc thnh 100 ml, trn u.

Dung dch chun: Cn chnh xc khong 50 mg loperamid hydroclorid chun , ho tan trong hn hp ng th tch acetonitril (TT) v dung dch acid hydrocloric 0,5 N (TT) va 250 ml. Pha long 5,0 ml dung dch ny thnh 100 ml bng hn hp ng th tch acetonitril (TT) v nc, trn u (dung dch c nng chnh xc khong 10 mg/ml).

iu kin sc k:

Ct thp khng g Cyano (25 cm 4 mm, kch thc ht 10 mm).

Detector quang ph t ngoi t bc sng 220 nm.

Tc dng: 2,0 ml/pht.

Th tch tim: 50 ml.

Cch tin hnh:

Tin hnh sc k vi dch chun, s a l thuyt ca ct phi khng nh hn 1900; h s dung lng khng nh hn 3,5 v lch chun tng i ca din tch pic loperamid hydroclorid trong 6 ln tim lp li khng c ln hn 2,0%.

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

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

 

Bo qun

Trong ng kn, nhit khng qu 30 OC.

Loi thuc

Thuc tr i chy

 

Hm lng thng dng

2 mg (tnh theo loperamid hydroclorid).