Nang clindamycin

Capsulae Clindamycini

 

L nang cng c cha clindamycin 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 clindamycin, C18H33ClN2O5S, t 90,0 n 110,0% so vi lng ghi trn nhn

 

Tnh cht

Nang cng, bt thuc trong nang mu trng ng.

 

nh tnh

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

B. Phi c phn ng c trng ca ion clorid (Ph lc 8.1).

 

Nc

Khng qu 7,0% .

Dng khong 1,00 g bt thuc (Ph lc 10.3).

 

ho tan (Ph lc 11.4).

Thit b: Kiu gi quay.

Tc quay: 100 vng/pht.

Mi trng ho tan: 900 ml Dung dch m phosphat pH 6,8 (TT).

Thi gian: 30 pht.

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

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

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

Dung dch chun: Pha dung dch clindamycin hydroclorid chun trong nc c nng tng t nh dung dch th.

Yu cu: Khng c t hn 80,0% lng clindamycin, C18H33ClN2O5 S , so vi lng ghi trn nhn c ho tan trong 30 pht.

 

nh lng

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

Pha ng: Hn hp ca methanol (TT) v dung dch A (30: 21).

Dung dch A: Ho tan 2,88 g amoni dihydrophosphat (TT) trong 1000 ml nc, iu chnh ti pH 3,0 vi dung dch acid phosphoric 80% .

Dung dch th: Cn thuc trong 20 nang, tnh khi lng trung bnh ca thuc trong mt nang, nghin thnh bt mn, trn u. Cn chnh xc mt lng bt ch phm tng ng vi khong 50 mg clindamycin hydroclorid chuyn vo bnh nh mc 25 ml, thm 20 ml pha ng, lc siu m ho tan, thm pha ng ti vch. Lc u v lc.

Dung dch chun: Cn chnh xc khong 50 mg clindamycin hydroclorid chun ho tan trong pha ng va 25,0 ml.

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 215 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, s a l thuyt ca ct phi khng t hn 1300.

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

Tnh hm lượng clindamycin, C18H33ClN2O5S, c trong chế phẩm dựa vo diện tch pic thu được từ sắc k đồ của dung dịch thử, dung dịch chuẩn v hm lượng C18H33ClN2O5S, trong clindamycin hydroclorid chun.

Bo qun

Trong ng kn, nhit khng qu 30 OC.

 

Loi thuc

Khng sinh

 

Hm lng thng dng

75 mg, 150 mg v 300 mg (tnh theo clindamycin).