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)*1C150109E

System suitability
requirement

ResultResolution (1, 2)≧1015.5

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

1mAU
160

F

F

CH3FO

140

S

2O

NN

NH

120
100

Lansoprazole

8060

240

CH3O

20
H 3C

0C150109E

min2ColumnEluent
Flow rate
Temperature

4681012O

4'-Ethoxyacetophenone (I.S.): YMC-Triart C18 (5 µm, 12 nm)
250 X 4.6 mmI.D.
: acetonitrile/water/TEA*2 (40/60/1) adjusted to pH 7.0 with phosphoric acid: 1.5 mL/min (adjust the flow rate so that the retention time of Lansoprazole is about 7 min)
: 25℃

Detection: UV at 285 nm
Injection: 10 µL(The draft for the Japanese Pharmacopoeia; Assay)*1Standard solution was prepared from Lansoprazole supplied as a reagent for laboratory use.

*2

triethylamine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*1(0.0025 mg/mL Lansoprazole)
System suitability
requirement

ResultTheoretical 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) tostandard solution(Lansoprazole)

4-6%5.0%mAU
80
7060

150
403020100 C150113E
051015202530

354045min#1(B) Sample solution*1(0.25 mg/mL Lansoprazole)

FFCH3F1OmAU80SON
N70NH605040Lansoprazole

3020100 C150115B
051015202530354045min#Column: YMC-Triart C18 (5 µm, 12 nm)
150 X 4.6 mmI.D.
Eluent: A) waterB) acetonitrile/water/TEA*2 (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)*1

All standard and sample solutions were prepared from Lansoprazole supplied as a reagent for laboratory use.

*2

triethylamine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*1(0.0025 mg/mL Lansoprazole)
System suitability
requirement

ResultTheoretical plate number(Lansoprazole)≧150000

201200

Tailing factor(Lansoprazole)

≦1.5

1.07

Relative standard deviation ofthe peak area (n=6)(Lansoprazole)≦3.0%0.75%

Peak area ratio of test
solution for required
detectability (0.125 µg/mL) tostandard solution(Lansoprazole)

4-6%

5.4%mAU807060

150403020100C150115D

05101520253035min#1(B) Sample solution*1(0.25 mg/mL Lansoprazole)FF

1mAUCH3FO

80
70SON
N

60

NH

50
40
30

Lansoprazole

20100C150115E

051015202530

35min#Column: YMC-Triart C18 (5 µm, 12 nm)
150 X 4.6 mmI.D.
Eluent: A) waterB) acetonitrile/water/TEA*2 (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)*1

All standard and sample solutions were prepared from Lansoprazole supplied as a reagent for laboratory use.

*2

triethylamine