シンバスタチン（日本薬局方記載条件）
Simvastatin (The Japanese Pharmacopoeia)

U120619B

1H

H3C

CH3H3CA) Standard solution*(1.5 mg/mL Simvastatin)

O H

H

H3C

CH3OO

H

CH3H

H3C
H

Simvastatin

Lovastatin

700
600
500

System suitability
requirement

Result

≦1.0%

0.44%

400

Relative standard
deviation of the peak area(Simvastatin)

300
200100

U120601B

00123min4B) System suitability solution*(1.5 mg/mL Lovastatin, 1.5 mg/mL Simvastatin)
2mAU
1200

1000

1800600

Resolution (1, 2)

400

System suitability
requirement

Result≧35.6200
U120601C001234OHHH800OH

HO H

CH3H3C1HHOmAUOOH2OHminColumn: YMC-Triart C18 (3 µm, 12 nm)

EluentFlow rate

35 X 4.6 mmI.D.
: acetonitrile/water/phosphoric acid (50/50/0.05): 3.0 mL/min (adjust the flow rate so that the retention time of simvastatin is about 3 min)Temperature: 25℃

Detection: UV at 238 nm

Injection: 5 µL(The Japanese Pharmacopoeia 16th; Assay)* All solutions were prepared from Simvastatin supplied as a reagent for laboratory use.

シンバスタチン錠（日本薬局方収載原案記載条件）
Simvastatin tablets (The draft for the Japanese Pharmacopoeia)

U120608CA) Assay: Standard solution*1(0.1 mg/mL Simvastatin)
System suitability
requirement

ResultTheoretical plate number(Simvastatin)

≧6000

17600

Talling factor(Simvastatin)

0.9≦Tf≦1.1

0.98

Relative standard
deviation of the peak area(Simvastatin)

≦1.0%

0.07%

1mAU
140
120
100
80
60
40

H

1OH

200U120606A
0H3C
5101520

CH3minH3C

O HHHHOB) Related substances: Standard solution*(0.0005 mg/mL Simvastatin)

16CH3H

H3CHSimvastatin

System suitability
requirement

ResultTheoretical plate number(Simvastatin)

≧6000

17200

Talling factor(Simvastatin)

0.9≦Tf≦1.1

1.00

Relative standard
deviation of the peak area(Simvastatin)≦2.0%

1.05%mAU

8OO

42

10U120606B
05101520min

Column: YMC-Triart C18 (5 µm, 12 nm)

Eluent

250 X 4.6 mmI.D.
: phosphate buffer (pH 4.5)*2/acetonitrile (35/65)
2* Dissolve 3.90 g of NaH2PO4･2H2O in 900 mL water, adjust pH 4.5 with H3PO4, and add
water to make 1000 mL

Flow rate: 1.8 mL/min (adjust the flow rate so that the retention time of simvastatin is about 9 min)Temperature: 45℃

Detection
Injection: UV at 238 nm: 10 µL(The draft for the Japanese Pharmacopoeia; Assay, Related substances)1* All standard solutions were prepared from Simvastatin supplied as a reagent for laboratory use.

シンバスタチン錠（日本薬局方収載原案記載条件）
Simvastatin tablets (The draft for the Japanese Pharmacopoeia)

U120608B

1
H

H3C

H

CH3

H3C

Standard solution*(0.0055 mg/mL Simvastatin)OHOOO HHHO

CH3
H

H3C
H

1mAUSimvastatin
2520System suitability
requirement

ResultTheoretical plate number(Simvastatin)

≧3000

6000

10Talling factor(Simvastatin)

≦2.0

0.99

5Relative standard
deviation of the peak area(Simvastatin)

≦1.0%

0.05%

15001234567min

Column: YMC-Triart C18 (5 µm, 12 nm)

EluentFlow rate
Temperature

150 X 4.0 mmI.D.
: methanol/0.02 M KH2PO4 (4/1): 1.3 mL/min (adjust the flow rate so that the retention time of simvastatin is about 4 min)
: 50℃

Detection: UV at 238 nm

Injection: 20 µL(The draft for the Japanese Pharmacopoeia; Dissolution)* Standard solution was prepared from Simvastatin supplied as a reagent for laboratory use.

シンバスタチン（米国薬局方記載条件）
Simvastatin (The United States pharmacopeia)

U120622AA) Standard preparation*A) (1.5 mg/mL Simvastatin)

1H

OH

1mAU

H3C

CH3

H
O

800

O H

700
600

OSystem suitability
requirement

Result

≦1.0%

0.19%

H

H

Relative standard
deviation of the peak area(Simvastatin)

300

CH3

H3C

500
400

HOH

Simvastatin

200
100

2U120601D

HOH00246810min

H3CB) System suitability preparation*B) (0.015 mg/mL Lovastatin, 1.5 mg/mL Simvastatin)

HO
O HO

HO

H
CH3H1mAU

CH3H3C
H

800
700

Lovastatin

600
500400300

System suitability
requirement

Result≧35.5

Resolution (1, 2)

200

2100U120601E
002

46810minColumn: YMC-Triart C18 (3 µm, 12 nm)

Eluent35 X 4.6 mmI.D.
: A) acetonitrile/water/phosphoric acid (50/50/0.05)
B) acetonitrile/phosphoric acid (100/0.1)
0%B(0-4.5 min), 0-5%B(4.5-4.6 min), 5-75%B(4.6-8.0 min), 75%B(8.0-11.5 min)Flow rate: 3.0 mL/min

Temperature: 25℃Detection: UV at 238 nmInjection: 5 µL(The United States Pharmacopeia 34th; Assay)* All preparations were prepared from Simvastatin supplied as a reagent for laboratory use.

シンバスタチン錠（米国薬局方記載条件）
Simvastatin tablets (The United States Pharmacopeia)

U120605E

1
H

H3C

Standard preparation*(0.1 mg/mL Simvastatin)

H

CH3

1

H3C

OO

O H

H

HO

CH3H

H3C

1mAU

OH

H

Simvastatin

140120
System suitabilityrequirement

ResultCapacity factor(Simvastatin)≧3.05.69

Theoretical plate number(Simvastatin)

≧4500

19200

Talling factor(Simvastatin)

≦2.0

0.98

Relative standard
deviation of the peak area(Simvastatin)

≦2.0%

0.12%

1008060

40200024Column

68101214 min: YMC-Triart C18 (5 µm, 12 nm)
250 X 4.6 mmI.D.

Eluent: phosphate buffer (pH 4.5)*2/acetonitrile (35/65)
2* Dissolve 3.90 g of NaH2PO4･2H2O in 900 mL water, adjust pH 4.5 with H3PO4,and add water to make 1000 mL

Flow rate: 1.5 mL/min

Temperature: 45℃Detection: UV at 238 nm

Injection: 10 µL(The United States Pharmacopeia 34th; Assay)
1* Standard preparation was prepared from Simvastatin supplied as a reagent for laboratory use.