クロピドグレル硫酸塩（日本薬局方原案記載条件）
Clopidogrel Sulfate (The draft for the Japanese Pharmacopoeia) H130711G
Standard solution*1

1CH3(0.126 mg/mL Clopidogrel sulfate)OO
Cl・H2SO 4N
S

1mAU

Clopidogrel sulfate
160
Systemsuitability
requirement

ResultTheoretical plate number(Clopidogrel)

≧4500

13900

Tailing factor (Clopidogrel)

≦2.0

0.80

Relative standard devition ofpeak area (Clopidogrel)

≦1.0%

0.12%

140
120
100
80
60
40
20002Column
Eluent4681012 min: YMC-Pack Pro C18 (5 µm, 12 nm)
150 X 4.0 mmI.D.
: A) buffer*2/methanol (19/1)
B) acetonitrile/methanol (19/1)
A/B (3/2)
2* Dissolve 0.87 g of sodium 1-pentanesulfonate in 1000 mL water, adjust pH 2.5
with H3PO4

Flow rate
Temperature
Detection: 1.1 mL/min (adjust the flow rate so that the retention time of Clopidogrel is about 8 min)
: 30℃
: UV at 220 nm

Injection: 10 µL(The draft for the Japanese Pharmacopoeia; Assay)*1 Standard solution was prepared from Clopidogrel sulfate supplied as a reagent for laboratory use.

クロピドグレル硫酸塩（日本薬局方原案記載条件）
Clopidogrel Sulfate (The draft for the Japanese Pharmacopoeia)(A) Standard solution*1

Systemsuitability
requirement

ResultTheoretical plate number(Clopidogrel)≧60000155300

Tailing factor (Clopidogrel)

≦2.0

0.97

Relative standard deviation ofpeak area (Clopidogrel)

≦2.0%

0.30

(6.5 µg/mL Clopidogrel sulfate)

1mAU

864
20-2-4-6

H130704D

H130704B

01020304050

6070min(B) Sample solution*1(6.5 mg/mL Clopidogrel sulfate)

CH3

1OOCl

1NmAU・H2SO4S

8060

Clopidogrel Sulfate

402000ColumnEluent

H130704C

10302040506070min: YMC-Pack Pro C18 (5 µm, 12 nm)
150 X 4.0 mmI.D.
: A) buffer*2/methanol (19/1)
B) acetonitrile/methanol (19/1)
2* Dissolve 0.87 g of sodium 1-pentanesulfonate in 1000 mL water, adjust pH 2.5
with H3PO4

Flow rate

10.5%B (0-3 min), 10.5-68.5%B (3-48 min), 68.5%B (48-68 min)
: 1.0 mL/min

Temperature: 30℃
Detection: UV at 220 nm
Injection: 10 µL(The draft for the Japanese Pharmacopoeia; Related substances)
1* All standard and sample solutions were prepared from Clopidogrel sulfate supplied as a reagent for laboratory use.

クロピドグレル硫酸塩錠（日本薬局方原案記載条件）
Clopidogrel Sulfate Tablets (The draft for the Japanese Pharmacopoeia)
H130716G(A) Standard solution*1(0.133 mg/mL Isopropyl benzoate, 0.1 mg/mL Clopidogrel)
mAU
250

12200

Systemsuitability
requirement

Result150

Resolution (1,2)

≧4

13.1

100

Relative standard deviation ofthe peak area ratio 1 to 2

≦1.0%

0.03%

50
H130716B

0204681210min

1OOCH3CH3(B) Sample solution*2(0.133 mg/mL Isopropyl benzoate, 0.1 mg/mL Clopidogrel)
Isopropyl benzoate (I.S.)

mAU

1250

22200

CH3OOCl

150
N・H2SO4100
S50

Clopidogrel sulfate
H130716A

00ColumnEluent

24681012min: YMC-Pack Pro C18 (5 µm, 12 nm)
150 X 4.0 mmI.D.
: A) buffer*3/methanol (19/1)
B) acetonitrile/methanol (19/1)
A/B (3/2)
3* Dissolve 0.87 g of sodium 1-pentanesulfonate in 1000 mL water, adjust pH 2.5
with H3PO4Flow rate
: 1.1 mL/min (adjust the flow rate so that the retention time of Clopidogrel is about 8 min)Temperature: 30℃
Detection: UV at 220 nm
Injection: 10 µL(The draft for the Japanese Pharmacopoeia; Assay)*1 Standard solution was prepared from Clopidogrel sulfate supplied as a reagent for laboratory use.
*2 Sample solution was prepared from Clopidogrel sulfate tablets.