ランソプラゾール（日本薬局方収載原案記載条件） Lansoprazole (The;pdf

ランソプラゾール（日本薬局方収載原案記載条件）
Lansoprazole (The draft for the Japanese Pharmacopoeia)
C150109E
System suitability
requirement
Result
Resolution (1, 2)
≧10
15.5
Relative standard deviation of
the peak area ratio of 1 to 2 (n=6)
≦1.0%
0.10%
Standard solution*
(0.1 mg/mL Lansoprazole,
0.05 mg/mL 4'-Ethoxyacetophenone)
1
1
mAU
160
F
F
CH3
F
O
140
S
2
O
N
N
NH
120
100
Lansoprazole
80
60
2
40
CH3
O
20
H 3C
0
C150109E
min
2
4
6
8
10
12
O
4'-Ethoxyacetophenone (I.S.)
Column
: Triart C18 plus (5 µm, 12 nm)
250 X 4.6 mmI.D.
Eluent
: acetonitrile/water/TEA (40/60/1) adjusted to pH 7.0 with phosphoric acid
Flow rate
: 1.5 mL/min (adjust the flow rate so that the retention time of Lansoprazole is about 7 min)
Temperature
: 25℃
Detection
: UV at 285 nm
Injection
: 10 µL
(The draft for the Japanese Pharmacopoeia; Assay)
* Standard solution was prepared from Lansoprazole supplied as a reagent for laboratory use.
ランソプラゾール（日本薬局方収載原案記載条件）
Lansoprazole (The draft for the Japanese Pharmacopoeia)
C150304A
(A) Standard solution*
(0.0025 mg/mL Lansoprazole)
System suitability
requirement
Result
Theoretical plate number
(Lansoprazole)
≧150000
221000
Tailing factor
(Lansoprazole)
≦1.5
1.03
Relative standard deviation of
the peak area (n=6)
(Lansoprazole)
≦3.0%
0.06%
Peak area ratio of test
solution for required
detectability (0.125 µg/mL) to
standard solution
(Lansoprazole)
4-6%
5.0%
mAU
80
70
60
1
50
40
30
20
10
0 C150113E
0
5
10
15
20
25
30
35
40
45
min#
1
(B) Sample solution*
(0.25 mg/mL Lansoprazole)
F
F
CH3
F
1
O
mAU
80
S
O
N
N
70
NH
60
50
40
Lansoprazole
30
20
10
0 C150115B
0
5
10
15
20
25
30
35
40
45
min#
Column
: Triart C18 plus (5 µm, 12 nm)
150 X 4.6 mmI.D.
Eluent
: A) water
B) acetonitrile/water/TEA (160/40/1) adjusted to pH 7.0 with phosphoric acid
10-80%B (0-40 min), 80%B (40-50 min)
Flow rate
: 0.65 mL/min (adjust the flow rate so that the retention time of Lansoprazole is about 29 min)
Temperature
: 25℃
Detection
: UV at 285 nm
Injection
: 40 µL
(The draft for the Japanese Pharmacopoeia; Related substances)
* All standard and sample solutions were prepared from Lansoprazole supplied as a reagent for laboratory use.
ランソプラゾール腸溶性口腔内崩壊錠（日本薬局方収載原案記載条件）
Lansoprazole delayed-release orally disintegration tablets
(The draft for the Japanese Pharmacopoeia)
C150304B
(A) Standard solution*
(0.0025 mg/mL Lansoprazole)
System suitability
requirement
Result
Theoretical plate number
(Lansoprazole)
≧150000
201200
Tailing factor
(Lansoprazole)
≦1.5
1.07
Relative standard deviation of
the peak area (n=6)
(Lansoprazole)
≦3.0%
0.75%
Peak area ratio of test
solution for required
detectability (0.125 µg/mL) to
standard solution
(Lansoprazole)
4-6%
5.4%
mAU
80
70
60
1
50
40
30
20
10
0
C150115D
0
5
10
15
20
25
30
35
min#
1
(B) Sample solution*
(0.25 mg/mL Lansoprazole)
F
F
1
mAU
CH3
F
O
80
70
S
O
N
N
60
NH
50
40
30
Lansoprazole
20
10
0
C150115E
0
5
10
15
20
25
30
35
min#
Column
: Triart C18 plus (5 µm, 12 nm)
150 X 4.6 mmI.D.
Eluent
: A) water
B) acetonitrile/water/TEA (160/40/1) adjusted to pH 7.0 with phosphoric acid
10-80%B (0-30 min), 80%B (30-40 min)
Flow rate
: 0.65 mL/min (adjust the flow rate so that the retention time of Lansoprazole is about 24 min)
Temperature
: 25℃
Detection
: UV at 285 nm
Injection
: 40 µL
(The draft for the Japanese Pharmacopoeia; Related substances)
* All standard and sample solutions were prepared from Lansoprazole supplied as a reagent for laboratory use.

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