Nang clarithromycin

Capsulae Clarithromycini

 

L nang cng cha clarithromycin.

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 clarithromycin, C38H69NO13, phi t 90,0 n 110,0% so vi hm lng ghi trn nhn.

 

Tnh cht

Nang cng, bt thuc trong nang mu trng ng.

 

nh tnh

Trn sc k thu c phn nh lng, thi gian lu ca pic chnh trn sc k ca dung dch th phi tng ng vi thi gian lu vi ca pic clarithromycin trn sc k ca dung dch clarithromycin chun.

 

Nc

Khng qu 6,0%.

Cn chnh xc khong 0,25 g bt thuc, sy trong chn khng di p sut 5 mm Hg 110OC trong 3 gi ( Ph lc 9.6).

 

ho tan ( Ph lc 11.4 )

Thit b: Kiu cnh khuấy.

Mi trng ho tan: 900 ml dung dch m natri acetat 0,1 M.

Pha dung dch m natri acetat 0,1 M : Ho tan 13,61 g natri acetat trihydrat (TT) trong 1000 ml nc, iu chnh n pH 5,0 bng acid acetic 0,1 N (TT)).

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 nh trong phn nh lng.

Dung dch th : Ly 1 phn dung dch mi trng ha tan mu th, lc, b 20 ml dch lc u.. Pha long mt lng chnh xc dch lc vi pha ng c dung dch c nng clarithromycin khong 125 mg/ ml.

Yu cu: Khng c t hn 80,0% lng clarithromycin, C38H69NO13, 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 kalidihydrophosphat 0,067 M (65: 35), iu chnh n pH 4,0 bng acid phosphoric (TT). Lc qua mng 0,5 mm v ui kh. iu chnh t l nu cn.

Dung dch th: Cn 20 nang thuc, tnh khi lng trung bnh bt thuc trong nang, nghin thnh bt mn. Cn chnh xc mt lng bt thuc tng ng vi 0,2 g clarithromycin vo bnh nh mc 50 ml, thm khong 35 ml methanol (TT), lc trong 30 pht ri thm methanol (TT) ti nh mc, lng. Ly ng 3,0 ml dch trn thm pha ng va 100,0 ml, trn u v lc qua mng 0,45 mm.

Dung dch chun: Cn chnh xc mt lng clarithromycin chun pha trong methanol (TT), lc, siu m nu cn c dung dch gc c nng clarithromycin chun chnh xc khong 625 mg/ ml. Pha long 10,0 ml dung dch ny thnh 50,0 ml bng pha ng, trn u. Lc qua mng lc 0,45 mm. (Dung dch c nng clarithromycin chun chnh xc khong 125 mg/ ml ).

Dung dch phn gii: Pha cht lin quan A ca clarithromycin [6,11-di-o-methylerythromycin A,

C39 H71NO13,] trong methanol (TT) c dung dch c nng khong 625 mg/ ml. Ly 10,0 ml dung dch ny v 10,0 ml dung dch chun vo bnh nh mc 50 ml, thm pha ng va n vch v trn u.

iu kin sc k:

Ct thp khng g (15 cm 4,6 mm) cha pha tnh C (5 mm).

Detector quang ph t ngoi, t bc sng 210 nm.

Nhit ct duy tr khong 50 OC.

Tc dng: 1,0 ml/pht.

Th tch tim: 20 ml.

Cch tin hnh:

Kim tra kh nng thch hp ca h thng k: Trin khai sc k i vi dung dch phn gii, thi gian lu tng i ca clarithromycin khong 0,75 v ca cht lin quan A ca clarithromycin l 1,0. phn gii gia hai pic clarithromycin v cht lin quan A ca clarithromycin phi khng nh hn 2,0.

Trin khai sc k i vi dung dch chun, t pic ca clarithromycin tnh ra s a l thuyt ca ct khng c nh hn 750; h s i xng khng nh hn 0,9 v khng qu 2; lch chun tng i ca 6 ln tim lp li khng ln hn 2,0%.

Trin khai sc k ln lt i vi dung dch chun v dung dch th .

Tnh hm lượng clarithromycin, C38H69NO13, 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 C38H69NO13 trong clarithromycin chun.

 

Bo qun

Trong ng kn, nhit khng qu 30OC.

 

Loi thuc

Khng sinh macrolid.

 

Hm lng thng dng

250 mg, 500 mg.