Trihexyphenidyl Hydroclorid

Trihexiphenydyli hydrochloridum

 

 

 

C20H31NO. HCl P.t.l: 337.9

 

Trihexyphenidyl hydroclorid la (1RS)-1-cyclohexyl-1-phenyl-3-(piperidin-1-yl)propan-1-ol hydroclorid, phai cha t 99,0 % en 101,0 % C20H31NO. HCl, tnh theo che pham a lam kho.

Tnh chat

Bot ket tinh trang. Kho tan trong nc, hi t tan trong ethanol 96% va methylen clorid.

iem chay khoang 250 oC, kem theo s phan huy.

nh tnh

Co the chon 1 trong 2 nhom nh tnh sau:

Nhom 1: A, D

Nhom 2: B, C, D

A. Pho hong ngoai cua che pham (Phu luc 4.2) phai phu hp vi pho hong ngoai cua trihexyphenidyl hydroclorid chuan (ĐC).

B. Sac ky lp mong (Phu luc 5.4)

Ban mong: Silica gel G (TT).

Dung moi trien khai: Diethylamin - hexan (5 : 95).

Dung dch th: Hoa tan 25 mg che pham trong hon hp methanol - methylen clorid (20 : 80 va pha loang thanh 10 ml vi cung dung moi.

Dung dch oi chieu: Hoa tan 25 mg trihexyphenidyl hydroclorid chuan (C) trong hon hp methanol - methylen clorid (20 : 80) va pha loang thanh 10 ml vi cung dung moi.

Cach tien hanh: Cham rieng re 5 l moi dung dch len ban mong. Trien khai sac ky en khi dung moi i c khoang 12 cm. Lam kho ban mong trong khong kh, phun bang dung dch acid cloroplatinic 0,1 g/l pha trong acid hydrocloric 0,4 % (tt/tt). Vet chnh thu c t dung dch th phai tng ng ve v tr, mau sac va kch thc so vi vet chnh thu c t dung dch oi chieu tren cung tren sac ky o.

C. Hoa tan 0,5 g che pham trong 5 ml methanol (TT) nong va ieu chnh o kiem bang dung dch natri hydroxid (TT) oi chieu vi giay qu o (TT). Tua tao thanh, sau khi ket tinh lai trong methanol (TT), co iem chay khoang 113 115 oC (Phu luc 6.7).

D. Che pham phai cho phan ng (A) cua phep th nh tnh ion clorid (Phu luc 8.1).

pH

T 5,2 en 6,2 (Phu luc 6.2)

Hoa tan 0,5 g che pham bang cach un nong trong 25 ml nc khong co carbon dioxyd (TT). Lam nguoi en nhiet o phong va pha loang thanh 50 ml bang nc khong co carbon dioxyd (TT).

Goc quay cc

T -0,10o en +0,10o (Phu luc 6.4)

Hoa tan 1,25 g che pham trong hon hp methanol - methylen clorid (20 : 80) va pha loang thanh 25,0 ml vi cung dung moi.

Tap chat lien quan

Tien hanh theo phng phap sac ky long (Phu luc 5.3)

Pha ong: Tron 200 ml nc vi 0,2 ml triethylamin (TT). ieu chnh pH en 4,0 bang acid phosphoric (TT) va them tiep 800 ml acetonitril (TT).

Dung dch th: Hoa tan 20,0 mg che pham trong pha ong va pha loang thanh 10,0 ml vi cung dung moi.

Dung dch oi chieu (1): Pha loang 1,0 ml dung dch th thanh 200,0 ml bang pha ong. Pha loang 10,0 ml dung dch nay thanh 50,0 ml bang pha ong.

Dung dch oi chieu (2): Hoa tan 10,0 mg tap cht chun A cua trihexyphenidyl (ĐC) [1-phenyl-3-(piperidin-1-yl)-propan-1-on] trong pha ong va pha loang thanh 10,0 ml vi cung dung moi.

Dung dch oi chieu (3): Pha loang 1,0 ml dung dch oi chieu (2) thanh 100,0 ml bang pha ong.

Dung dch oi chieu (4): Them 1,0 ml dung dch th vao 1,0 ml dung dch oi chieu (2), pha loang thanh 100,0 ml bang pha ong.

ieu kien sac ky:

Cot thep khong g (0,15 m x 4,6 mm) nhoi pha tĩnh C (5 m).

Toc o dong: 1,0 ml/phut.

Detector: Quang pho hap thụ t ngoai at ở bc song 210 nm.

The tch tiem: 20 l

Cach tien hanh:

Thi gian ra giai: Thi gian ra giai gap 3 lan thi gian lu cua trihexyphenidyl.

Kiem tra tnh on nh cua he thong bang cach tiem dung dch oi chieu (4). Phep th co gia tr khi o phan gia cac pic cua trihexynidyl va tap chat A t nhat la 4,0.

Tiem dung dch oi chieu (1), dung dch oi chieu (3) va dung dch th. Tren sac ky o thu c t dung dch th, dien tch pic cua tap chat A khong c ln hn dien tch pic chnh trong sac ky o thu c t dung dch oi chieu (3) (0,5%). Dien tch pic cua bat ky pic phu nao khac, khong c ln hn dien tch cua pic chnh trong sac ky o thu c t dung dch oi chieu (1) (0,1%). Tong ham lng cua tat ca cac pic tap khong c ln hn 0,5%.

Bo qua cac pic co dien tch nho hn 0,2 lan dien tch cua pic chnh trong sac ky o thu c t dung dch oi chieu (1) (0,02%).

Mat khoi lng do lam kho

Khong c qua 0,5% (Phu luc 9.6)

(1,000 g; 100 105 oC).

Tro sulfat

Khong c qua 0,1% (Phu luc 9.9; Phng phap 2).

Dung 1,0 g che pham.

nh lng

Hoa tan 0,250 g che pham trong 50 ml ethanol 96% (TT) va them 5,0 ml dung dch acid hydrocloric 0,01 M (C). Tien hanh chuan o theo phng phap chuan o o ien the (Phu luc 10.2) dung dung dch natri hydroxid 0,1 M (C). oc the tch dung dch chat chuan o tai 2 iem uon.

1 ml dung dch natri hydroxid 0,1 M (C) tng ng 33,79 mg C20H32ClNO.

Loi thuc

ieu tr benh Parkinsons.

Che pham

Vien nen, vien tac dung keo dai.