モンテルカストナトリウム錠（日本薬局方原案記載条件） Montelukast

モンテルカストナトリウム錠（日本薬局方原案記載条件）
Montelukast sodium tablets (The draft for The Japanese Pharmacopoeia)
H150501A
(A) Dissolution: Standard solution
(5.5 µg/mL Montelukast)
*1
1
mAU
250
200
150
100
50
H150204K006
0
0.0
1.0
2.0
3.0
4.0
System
suitability
requirement
Result
≧2000
6100
≦1.5
1.10
≦2.0%
0.05%
System
suitability
requirement
Result
≧2000
4500
≦1.5
1.13
≦1.0%
0.06%
Theoretical plate number
(Montelukast)
Tailing factor
(Montelukast)
Relative standard devition
of peak area (n=5)
(Montelukast)
min
*1
(B) Uniformity of dosage units: Standard solution
(0.025 mg/mL Montelukast)
mAU
1
200
150
100
50
H150204C006
0
0.0
1.0
2.0
3.0
4.0
(C) Uniformity of dosage units: Sample solution
(0.025 mg/mL Montelukast)
mAU
Theoretical plate number
(Montelukast)
Tailing factor
(Montelukast)
Relative standard devition
of peak area (n=5)
(Montelukast)
min
*2
1
200
150
N
CH3
100
HO
50
Cl
CH3
S
H150428K006
0
O
0.0
1.0
2.0
3.0
4.0
min
OH
1. Montelukast
Column
: YMC-Pack Ph (5 µm, 12 nm)
Eluent
100 X 3.0 mmI.D.
: acetonitrile/water/TFA (500/500/2)
Flow rate
: 0.9 mL/min (adjust the flow rate so that the retention time of montelukast is about 2 min)
Temperature
: 50℃
Detection
: UV at 389 nm
Injection
: A) 50 µL, B),C) 10 µL
(The draft for The Japanese Pharmacopoeia 17th; Dissolution, Uniformity of dosage units)
*1
All standard solutions ware prepared from Montelukast sodium salt hydrate supplied as a reagent for laboratory use.
*2
Sample solution was prepared from Montelukast sodium tablets.
モンテルカストナトリウム錠（米国薬局方原案記載条件）
Montelukast sodium tablets (The draft for The United States Pharmacopoeia)
H150501B
(A) Dissolution: Standard solution
(5.4 µg/mL Montelukast)
mAU
*1
1
100
Tailing factor
(Montelukast)
Relative standard
devition of peak
area (n=5)
(Montelukast)
80
60
40
20
H150204F006
0
1.0
0.0
2.0
(B) Uniformity of dosage units: Standard solution
(0.039 mg/mL Montelukast)
mAU
≦1.5
1.08
≦2.0%
0.05%
System
suitability
requirement
Result
≦1.5
1.15
≦2.0%
0.06%
*1
1
300
Tailing factor
(Montelukast)
Relative standard
devition of peak
area (n=5)
(Montelukast)
200
100
0
0.0
Result
min
4.0
3.0
System
suitability
requirement
H150204A006
1.0
2.0
3.0
4.0
(C) Uniformity of dosage units: Sample solution
(0.04 mg/mL Montelukast)
mAU
min
*2
1
300
N
CH3
200
HO
CH3
S
100
H150428L006
0
0.0
Cl
1.0
2.0
3.0
4.0
min
Column
: YMC-Pack Ph (5 µm, 12 nm)
Eluent
100 X 3.0 mmI.D.
: acetonitrile/water/TFA (500/500/2)
Flow rate
: 0.9 mL/min
Temperature
: 50℃
Detection
: UV at 389 nm
Injection
: A) 20 µL, B), C) 10 µL
O
OH
1. Montelukast
(The draft for The United States Pharmacopoeia 40th; Dissolution, Uniformity of dosage units)
*1
All Standard solutions ware prepared from Montelukast sodium salt hydrate supplied as a reagent for laboratory use.
*2
Sample solution was prepared from Montelukast sodium tablets.
モンテルカストナトリウム顆粒（米国薬局方原案記載条件）
Montelukast sodium oral granules (The draft for The United States Pharmacopoeia)
H150501C
(A) Dissolution: Standard solution
(4.4 µg/mL Montelukast)
mAU
System
suitability
requirement
Result
Tailing factor
(Montelukast)
≦1.5
1.08
Relative standard devition
of peak area (n=5)
(Montelukast)
≦2.0%
0.12%
System
suitability
requirement
Result
≦1.5
1.09
≦2.0%
0.15%
1
125
100
75
50
25
H150204G006
0
0.0
0.5
1.0
1.5
2.0
2.5
3.0
3.5
4.0
4.5
min
(B) Uniformity of dosage units: Standard solution
(0.020 mg/mL Montelukast)
mAU
100
1
Tailing factor
(Montelukast)
Relative standard devition
of peak area (n=5)
(Montelukast)
80
60
40
N
CH3
20
HO
0.0
0.5
1.0
1.5
2.0
2.5
3.0
3.5
4.0
4.5
Column
: YMC-Pack Ph (5 µm, 12 nm)
Eluent
100 X 3.0 mmI.D.
: acetonitrile/water/TFA (500/500/2)
Flow rate
: 0.9 mL/min
Temperature
: 50℃
Detection
: UV at 389 nm
Injection
: A) 25 µL, B) 5 µL
CH3
S
H150204B006
0
Cl
min
O
OH
1. Montelukast
(The draft for The United States Pharmacopoeia 40th; Dissolution, Uniformity of dosage units)
*All Standard solutions were prepared from Montelukast sodium salt hydrate supplied as a reagent for laboratory use.

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