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)*11mAU
250
200
150
10050

H150204K006

00.0

1.0

2.0

3.0

4.0

Systemsuitability
requirement

Result

≧2000

6100

≦1.5

1.10

≦2.0%

0.05%

Systemsuitability
requirement

Result

≧2000

4500

≦1.5

1.13

≦1.0%

0.06%

Theoretical plate number(Montelukast)
Tailing factor(Montelukast)
Relative standard devitionof peak area (n=5)(Montelukast)min*1(B) Uniformity of dosage units: Standard solution(0.025 mg/mL Montelukast)
mAU

1200
150
100
50
H150204C006

00.0

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 devitionof peak area (n=5)(Montelukast)

min
*2

1200
150N
CH3100

HO50

Cl

CH3S

H150428K006

0O

0.0

1.0

2.0

3.0

4.0minOH

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*11100

Tailing factor(Montelukast)
Relative standard
devition of peakarea (n=5)(Montelukast)

80
60
40
20
H150204F006

01.00.02.0(B) Uniformity of dosage units: Standard solution(0.039 mg/mL Montelukast)
mAU

≦1.5

1.08

≦2.0%

0.05%

Systemsuitability
requirement

Result

≦1.5

1.15

≦2.0%

0.06%

*1

1300

Tailing factor(Montelukast)
Relative standard
devition of peakarea (n=5)(Montelukast)

200
10000.0

Resultmin

4.0

3.0System
suitability
requirementH150204A006

1.02.03.04.0(C) Uniformity of dosage units: Sample solution(0.04 mg/mL Montelukast)
mAUmin*21300
NCH3200

HOCH3S

100
H150428L00600.0Cl

1.02.03.04.0min

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

OOH

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

Systemsuitability
requirement

ResultTailing factor(Montelukast)

≦1.5

1.08

Relative standard devitionof peak area (n=5)(Montelukast)

≦2.0%

0.12%

Systemsuitability
requirement

Result≦1.5

1.09≦2.0%

0.15%

1125
10075
5025H150204G006

0
0.0

0.5

1.0

1.5

2.0

2.5

3.0

3.5

4.0

4.5min(B) Uniformity of dosage units: Standard solution(0.020 mg/mL Montelukast)
mAU
100

1

Tailing factor(Montelukast)
Relative standard devitionof peak area (n=5)(Montelukast)

80

60

40
N
CH320

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/minTemperature: 50℃

Detection: UV at 389 nm

Injection: A) 25 µL, B) 5 µL

CH3S

H150204B0060ClminOOH

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.