Olmesartan Medoxomil (The Japanese Pharmacopoeia)

オルメサルタンメドキソミル（日本薬局方記載条件）
Olmesartan Medoxomil (The Japanese Pharmacopoeia)
F150113K
Standard solution*1
(0.05 mg/mL Olmesartan medoxomil, 0.025 mg/mL p-Hydroxybenzoic acid isobutyl ester)
mAU
System
suitability
requirement
Result
Resolution
(1, 2)
≧4
9.4
Relative standard deviation
of the peak area ratio of 1 to 2 (n=6)
≦0.5%
0.30%
1
40
2
1
30
CH3
O
O
O
O
N
20
N
O
N
HO
NH
N
CH3
N
CH3
H3C
10
Olmesartan medoxomil
2
CH3
H3C
0
0
5
10
15
20
25
O
O
OH
min
p-Hydroxybenzoic acid isobutyl ester (I.S.)
Column
Eluent
: YMC-Triart C18 ExRS (5 µm, 8 nm)
150 X 4.6 mmI.D.
: phosphate buffer (pH 3.4)*2/acetonitrile (33/17)
*2 Dissolve 2.04 g of KH2PO4 in 1000 mL water, adjust pH to 3.4 with a solution of
1.73 g of phosphoric acid in 1000 mL water
Flow rate
: 1.2 mL/min
(adjust the flow rate so that the retention time of olmesartan medoxomil is about 16 min)
Temperature : 40℃
Detection
: UV at 250 nm
Injection
: 10 µL
(The Japanese Pharmacopoeia 16th 2nd supplement; Assay)
*1 Standard solution was prepared from Olmesartan medoxomil supplied as a reagent for laboratory use.
オルメサルタンメドキソミル錠（日本薬局方記載条件）
Olmesartan Medoxomil Tablets (The Japanese Pharmacopoeia)
F150113J
Standard solution*1
(0.04 mg/mL Olmesartan medoxomil, 0.01 mg/mL p-Hydroxybenzoic acid isobutyl ester)
mAU
System
suitability
requirement
Result
Resolution
(1, 2)
≧4
9.3
Relative standard deviation
of the peak area ratio of 1 to 2 (n=6)
≦1.0%
0.85%
40
1
1
30
CH3
O
O
O
O
N
20
N
O
N
HO
NH
N
CH3
N
2
CH3
H3C
10
Olmesartan medoxomil
2
CH3
H3C
0
0
5
10
15
20
25
O
O
OH
min
p-Hydroxybenzoic acid isobutyl ester (I.S.)
Column
Eluent
: YMC-Triart C18 ExRS (5 µm, 8 nm)
150 X 4.6 mmI.D.
: phosphate buffer (pH 3.4)*2/acetonitrile (33/17)
*2 Dissolve 2.04 g of KH2PO4 in 1000 mL water, adjust pH to 3.4 with a solution of
1.73 g of phosphoric acid in 1000 mL water
Flow rate
: 1.2 mL/min
(adjust the flow rate so that the retention time of olmesartan medoxomil is about 16 min)
Temperature : 40℃
Detection
: UV at 250 nm
Injection
: 10 µL
(The Japanese Pharmacopoeia 16th 2nd supplement; Assay)
*1 Standard solution was prepared from Olmesartan medoxomil supplied as a reagent for laboratory use.
オルメサルタンメドキソミル（米国薬局方記載条件）
Olmesartan Medoxomil (The United States Pharmacopeia)
F150119A
Standard solution*1
(0.05 mg/mL Olmesartan medoxomil, 0.025 mg/mL p-Hydroxybenzoic acid isobutyl ester)
System
suitability
requirement
Result
Resolution
(1, 2)
≧4
10.1
Relative standard deviation
of the peak area ratio of 1 to 2 (n=5)
≦0.5%
0.09%
mAU
1
40
2
1
30
CH3
O
O
O
O
N
N
20
O
N
HO
NH
N
CH3
N
CH3
H3 C
Olmesartan medoxomil
10
2
CH3
H3C
O
O
0
OH
0
Column
Eluent
5
10
15
20
25
min
p-Hydroxybenzoic acid isobutyl ester (I.S.)
: YMC-Triart C18 ExRS (5 µm, 8 nm)
150 X 4.6 mmI.D.
: 15 mM KH2PO4 buffer (pH 3.4)*2/acetonitrile (33/17)
*2 Adjust pH to 3.4 with 0.2% (w/v) phosphoric acid
Flow rate
: 1.0 mL/min
Temperature : 40℃
Detection
: UV at 250 nm
Injection
: 10 µL
(The United States Pharmacopeia 37th; Assay)
*1 Standard solution was prepared from Olmesartan medoxomil supplied as a reagent for laboratory use.

Download Report