アリピプラゾール (米国薬局方記載条件) Aripiprazole (The United

アリピプラゾール (米国薬局方記載条件)
Aripiprazole (The United States Pharmacopeia)
*1
H140204A
*1
(A) Standard solution , Sample solution
(0.1 mg/mL Aripiprazole)
1
mAU
350
300
250
Relative standard
deviation of the peak area
(Aripiprazole)
200
150
System
suitability
requirement
Result
≦1.0%
0.13%
System
suitability
requirement
Result
100
50
H140129A
0
0
5
10
15
20
25
30
min
*1
(B) System suitability solution
(1.0 µg/mL Aripiprazole, 1.0 µg/mL Aripirazole related compound F)
12
mAU
6
4
2
Tailing factor
(Aripiprazole)
≦1.5
1.03
0
Resolution (1,2)
≧2.0
4.49
-2
-4
H140129B
5
0
15
10
O
1
Cl
Cl
25
20
H
N
30
O
N
min
O
O
2
N
Aripiprazole
Column
Cl
Cl
H
N
O
N
N
Aripiprazole related compound F
: YMC-Pack ODS-A (3 µm, 12 nm)
100 X 4.6 mmI.D.
Eluent
: A) acetonitrile/0.05 % TFA (10/90)
B) acetonitrile/0.05 % TFA (90/10)
20%B (0-2 min), 20-35%B (2-10 min), 35-90%B (10-20 min), 90%B (20-25 min),
90-20%B (25-26 min), 20%B (26-35 min)
Flow rate
: 1.2 mL/min
Temperature
: 25℃
Detection
: UV at 254 nm
Injection
: 20 µL
(The United States Pharmacopeia 36th; Assay, Impurities)
1
* All solutions were prepared from aripiprazole and aripiprazole related compound F supplied as a reagent for
laboratory use.